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Trial record 9 of 17 for:    "Connective Tissue Disease" | "Ethanol"

A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)

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ClinicalTrials.gov Identifier: NCT00628901
Recruitment Status : Completed
First Posted : March 5, 2008
Results First Posted : August 22, 2011
Last Update Posted : July 11, 2012
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Leiomyoma
Uterine Fibroids
Uterine Neoplasms
Menorrhagia
Leiomyomatosis
Interventions Procedure: Uterine Fibroid Embolization (UFE)
Device: Contour SE™ Microspheres
Device: Embosphere® Microspheres
Enrollment 60
Recruitment Details Participants undergoing Uterine Fibroid Embolization for symptomatic uterine fibroids at the participating site, that met the study inclusion criteria, were approached for consent for inclusion into the study. Enrollment occurred from February 2006 to December 2009.
Pre-assignment Details  
Arm/Group Title Contour SE Microspheres Embosphere Microspheres
Hide Arm/Group Description Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Period Title: Overall Study
Started 30 30
Completed 27 29
Not Completed 3 1
Arm/Group Title Contour SE Microspheres Embosphere Microspheres Total
Hide Arm/Group Description Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids. Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
 100.0%
30
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
43.9  (5) 41.7  (5.4) 42.8  (5.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
30
 100.0%
30
 100.0%
60
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Hispanic or Latino
0
   0.0%
1
   3.3%
1
   1.7%
Not Hispanic or Latino
21
  70.0%
18
  60.0%
39
  65.0%
Unknown or Not Reported
9
  30.0%
11
  36.7%
20
  33.3%
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   6.7%
0
   0.0%
2
   3.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
21
  70.0%
20
  66.7%
41
  68.3%
White
7
  23.3%
6
  20.0%
13
  21.7%
More than one race
0
   0.0%
2
   6.7%
2
   3.3%
Unknown or Not Reported
0
   0.0%
2
   6.7%
2
   3.3%
[1]
Measure Description: Two participants in the Embosphere group had missing values for Race.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 30 participants 60 participants
30 30 60
Previous or concurrent gynecological disease(s)  
Measure Type: Number
Unit of measure:  Partcipants
Number Analyzed 30 participants 30 participants 60 participants
# of participants with concurrent gyneco disease 5 7 12
# of participants without concurrent gyneco diseas 25 23 48
Fibroid Related Symptoms   [1] 
Measure Type: Number
Unit of measure:  Particpants
Number Analyzed 30 participants 30 participants 60 participants
Abnormal Bleeding 28 27 55
Bulk/pressure 20 25 45
Pelvic Pain 22 23 45
Other 8 10 18
[1]
Measure Description: Fibroid related symptoms is collected on the baseline CRF. A participant may have multiple symptoms present, thus the number may not add up to 30 per group or 60 total. The analysis indicates the number of participants with each symptom, thus the sum for all categories in the arm/group does not equal the overall number of participants in the group.
Number of fibroids present greater than 2cm  
Measure Type: Number
Unit of measure:  Particpants
Number Analyzed 30 participants 30 participants 60 participants
0 fibroids 1 0 1
1 fibroid 1 3 4
2 fibroids 2 5 7
3 fibroids 10 4 14
4 fibroids 2 2 4
5 fibroids 2 2 4
6 fibroids 3 2 5
7-10 fibroids 6 5 11
>10 fibroids 3 7 10
Number of fibroids present less than 2 cm  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
0 fibroids 3 3 6
1 fibroid 2 3 5
2 fibroids 2 1 3
3 fibroids 3 1 4
4 fibroids 4 2 6
5 fibroids 2 4 6
6 fibroids 3 3 6
7-10 fibroids 4 4 8
>10 fibroids 7 9 16
Type of fibroid present   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Submucosal 16 20 36
Subserosal 26 24 50
Intramural 28 28 56
Transmural 14 17 31
Other, specify 0 0 0
Cannot determine 0 0 0
[1]
Measure Description: The type of fibroid present is determined from the baseline MRI. A participant may have more than one type of fibroid present, thus the number may not add up to 30 per group or 60 total. The analysis indicates the number of participants with each type of fibroid, thus the sum for all categories in the arm/group does not equal the overall number of participants in the group.
Dominant fibroid volume  
Mean (Standard Deviation)
Unit of measure:  Cm^3
Number Analyzed 30 participants 30 participants 60 participants
203.3  (275.1) 141.1  (179.6) 172.2  (232.5)
Uterine Volume  
Mean (Standard Deviation)
Unit of measure:  Cm^3
Number Analyzed 30 participants 30 participants 60 participants
1536.7  (937.3) 1491.6  (1456.5) 1514.2  (1214.5)
Maximal thickness of junctional zone  
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 30 participants 30 participants 60 participants
11.4  (6.6) 10.9  (7.9) 11.2  (7.2)
Maximal thickness of the endometrium  
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 30 participants 30 participants 60 participants
7.3  (2.8) 8.9  (3.3) 8.1  (3.2)
Minimal thickness of the myometrium  
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 30 participants 30 participants 60 participants
11.2  (5.1) 9.5  (4.2) 10.3  (4.7)
Concomitant adenomyosis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Focal 7 5 12
Diffuse 2 2 4
Cannot Determine 0 0 0
[1]
Measure Description:

This measure contains the number of subjects with concomitant adenomyosis. If concomitant adenomyosis was noted, it was further classified as focal or diffuse.

Not all subjects had concomitant adenomyosis noted. The sum for all categories in the arm/group does not equal the overall number of participants in the group, because the value only indicates if the measure was present.

Presence of endometrial scar  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Yes 0 0 0
No 30 30 60
Presence of myometrial scar  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Yes 7 7 14
No 23 23 46
Assessment of myometrial perfusion  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Normal 30 28 58
Mildly Decreased 0 1 1
Moderately Decreased 0 0 0
Severly Decreased/Infarcted 0 0 0
Ovaries seen  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Yes 29 29 58
No 1 1 2
Adnexal Pathology   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Endometrioma/Endometriosis 0 1 1
Cyst 3 2 5
Other 2 0 2
[1]
Measure Description:

This measure contains the number of subjects with adnexal pathology noted. If adnexal pathology was noted, it was further classified to be endometrioma/endometriosis, cyst, or other.

Not all subjects had adnexal pathology noted. The sum for all categories in the arm/group does not equal the overall number of participants in the group.

Obvious contribution to the uterine blood supply from the ovarian artery  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Yes 0 1 1
No 30 29 59
Maximal Thickness of the myometrium  
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 30 participants 30 participants 60 participants
26.8  (8.1) 25.0  (7.4) 25.9  (7.8)
1.Primary Outcome
Title Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI)
Hide Description MRI uses a large circular magnet and radio waves to generate signals from atoms in the body. These signals are used to construct images of internal structures. Injection of contrast through an IV is done during the test to enhance the view of the uterus. Contrast enhanced MRI was used as a test in this study to verify if blood supply to the fibroids was blocked or interrupted (devascularization).
Time Frame 24-hours post study procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Contour SE Microspheres Embosphere Microspheres
Hide Arm/Group Description:
Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Overall Number of Participants Analyzed 29 30
Measure Type: Number
Unit of Measure: participants
29 29
2.Secondary Outcome
Title Visual Analog Scale (VAS) Maximum Level of Nausea
Hide Description Maximum level of nausea was measured using the Visual Analog Scale(VAS). The patient is presented with a picture of a straight line that is 0-10 cm long. The left side of the line (0 cm) represents 'no nausea' and the right side (10cm) of the line represents 'worst nausea imaginable'. The patient is asked to place a mark on the line that represents their level of nausea. For example, a reading of 10cm = worst nausea imaginable.
Time Frame 24 hours after study procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Contour SE Microspheres Embosphere Microspheres
Hide Arm/Group Description:
Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: cm
5.5  (3) 4.8  (3.2)
3.Secondary Outcome
Title Visual Analog Scale (VAS) Maximum Level of Pain
Hide Description Maximum level of pain was measured using the Visual Analog Scale(VAS). The patient is presented with a picture of a straight line that is 0-10 cm long. The left side of the line (0 cm) represents 'no pain' and the right side (10cm) of the line represents 'worst imaginable'. The patient is asked to place a mark on the line that represents their level of pain. For example, a reading of 10cm = worst imaginable pain.
Time Frame 24 hours after study procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Contour SE Microspheres Embosphere Microspheres
Hide Arm/Group Description:
Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: cm
6.0  (2.9) 5.6  (2.8)
4.Secondary Outcome
Title Fluoroscopy Time
Hide Description Fluoroscopy is the method that provides real-time X ray imaging used for guiding a variety of diagnostic and interventional procedures. Fluoroscopy time is described as the amount of time the patient underwent fluoroscopy.
Time Frame During the study procedure (measured in minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Contour SE Microspheres Embosphere Microspheres
Hide Arm/Group Description:
Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: minutes
31.1  (19.4) 24.9  (8.7)
5.Secondary Outcome
Title Procedure Time
Hide Description Procedure time is the time in minutes of the first arterial puncture to time of hemostasis (stopping bleeding)
Time Frame During the study procedure (measured in minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Contour SE Microspheres Embosphere Microspheres
Hide Arm/Group Description:
Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: minutes
102  (49.9) 95.6  (39.6)
6.Secondary Outcome
Title Any Adverse Events That the Participant Experienced
Hide Description Summary of investigator reported adverse events and adverse device effects, including all serious adverse events and unanticipated adverse device effects. Adverse events were collected systematically, meaning they were collected during the participant's follow-up visit, during telephone contacts, or during medical record review.
Time Frame During the hospitalization stay post UFE
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Contour SE Microspheres Embosphere Microspheres
Hide Arm/Group Description:
Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: events
68 58
7.Secondary Outcome
Title Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score
Hide Description

The UFS-QoL asks the subjects feelings and experiences regarding the impact of uterine fibroid symptoms and experiences during the previous 3 months.

The scores are added and the final total scores range from 0-100. The lowest actual raw score=8, the highest raw score=40, the possible raw score range=32. A formula is then used to transform the value(actual raw score-lowest possible raw score divided by possible raw score range x100). Higher symptom score values are indicative of greater symptom severity or bother and lower scores indicate minimal symptom severity (high scores = bad)

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Contour SE Microspheres Embosphere Microspheres
Hide Arm/Group Description:
Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
64.2  (20.6) 65.1  (20.3)
8.Secondary Outcome
Title Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score
Hide Description

The UFS-QoL asks the subjects feelings and experiences regarding the impact of uterine fibroid symptoms and experiences during the previous 3 months.

The scores are added and the final total scores range from 0-100. The lowest actual raw score=8, the highest raw score=40, the possible raw score range=32. A formula is then used to transform the value(actual raw score-lowest possible raw score divided by possible raw score range x100). Higher symptom score values are indicative of greater symptom severity or bother and lower scores indicate minimal symptom severity (high scores = bad)

Time Frame 3-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Contour SE Microspheres Embosphere Microspheres
Hide Arm/Group Description:
Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
16.3  (12.1) 22.7  (20.5)
9.Secondary Outcome
Title Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score
Hide Description

The UFS-QoL asks the subjects feelings and experiences regarding the impact of uterine fibroid symptoms and experiences during the previous 3 months.

The scores are added and the final total scores range from 0-100.The lowest actual raw score=8, the highest raw score=40, the possible raw score range=32. A formula is then used to transform the value(actual raw score-lowest possible raw score divided by possible raw score range x100). Higher symptom score values are indicative of greater symptom severity or bother and lower scores indicate minimal symptom severity (high scores = bad).

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Contour SE Microspheres Embosphere Microspheres
Hide Arm/Group Description:
Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Overall Number of Participants Analyzed 26 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
18.0  (15.5) 22.9  (17.8)
10.Secondary Outcome
Title Health Related Quality of Life (HRQL)Subscores
Hide Description

The HRQL subscales (concern, activities, energy/mood, control, self-conscious, and sexual function were collected from the UFS-QoL.

Each individual subscale is added. HRQL Total (sum of 6 subscales); lowest possible raw score = 29, highest possible raw score=145. A formula is used to transform the HRQL raw scores (Highest possible score-actual raw score divided by possible raw score range x 100). Higher scores are indicative of a better HRQL and lower scores indicate a worse HRQL (High=good). The value reported for this measure is the average of all participants scores.

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Contour SE Microspheres Embosphere Microspheres
Hide Arm/Group Description:
Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
42.1  (20.2) 42.0  (23.7)
11.Secondary Outcome
Title Health Related Quality of Life Subscores
Hide Description

The HRQL subscales (concern, activities, energy/mood, control, self-conscious, and sexual function were collected from the UFS-QoL.

Each individual subscale is added. HRQL Total (sum of 6 subscales); lowest possible raw score = 29, highest possible raw score=145. A formula is used to transform the HRQL raw scores (Highest possible score-actual raw score divided by possible raw score range x 100). Higher scores are indicative of a better HRQL and lower scores indicate a worse HRQL (High=good). The value reported for this measure is the average of all participants scores.

Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Contour SE Microspheres Embosphere Microspheres
Hide Arm/Group Description:
Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: Scores
90.0  (13.1) 90.0  (11.7)
12.Secondary Outcome
Title Health Related Quality of Life Subscores
Hide Description

The HRQL subscales (concern, activities, energy/mood, control, self-conscious, and sexual function were collected from the UFS-QoL.

Each individual subscale is added. HRQL Total (sum of 6 subscales); lowest possible raw score = 29, highest possible raw score=145. A formula is used to transform the HRQL raw scores (Highest possible score-actual raw score divided by possible raw score range x 100). Higher scores are indicative of a better HRQL and lower scores indicate a worse HRQL (High=good). The value reported for this measure is the average of all participants scores.

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Contour SE Microspheres Embosphere Microspheres
Hide Arm/Group Description:
Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Overall Number of Participants Analyzed 25 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
89.8  (14.5) 89.9  (11.5)
Time Frame Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Contour SE Microspheres Embosphere Microspheres
Hide Arm/Group Description Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
All-Cause Mortality
Contour SE Microspheres Embosphere Microspheres
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Contour SE Microspheres Embosphere Microspheres
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/30 (3.33%)      3/30 (10.00%)    
Gastrointestinal disorders     
Mallory-Weiss syndrome  1  0/30 (0.00%)  0 1/30 (3.33%)  1
Musculoskeletal and connective tissue disorders     
Lumbar Spinal Stenosis  1  0/30 (0.00%)  0 1/30 (3.33%)  1
Reproductive system and breast disorders     
Endometriosis  1  1/30 (3.33%)  1 1/30 (3.33%)  1
Ovarian cyst  1  1/30 (3.33%)  1 0/30 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Contour SE Microspheres Embosphere Microspheres
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/30 (83.33%)      22/30 (73.33%)    
Gastrointestinal disorders     
Abdominal Pain  1  2/30 (6.67%)  2 2/30 (6.67%)  2
Constipation  1  3/30 (10.00%)  3 4/30 (13.33%)  5
Flatulence  1  0/30 (0.00%)  0 2/30 (6.67%)  2
Nausea  1  2/30 (6.67%)  2 1/30 (3.33%)  1
Vomiting  1  13/30 (43.33%)  14 11/30 (36.67%)  12
General disorders     
Fatigue  1  3/30 (10.00%)  3 0/30 (0.00%)  0
Pyrexia  1  0/30 (0.00%)  0 2/30 (6.67%)  2
Immune system disorders     
Hypersensitivity  1  0/30 (0.00%)  0 2/30 (6.67%)  2
Infections and infestations     
Infection  1  0/30 (0.00%)  0 2/30 (6.67%)  2
Injury, poisoning and procedural complications     
Procedural vomiting  1  4/30 (13.33%)  4 1/30 (3.33%)  1
Vascular Injury  1  0/30 (0.00%)  0 3/30 (10.00%)  3
Musculoskeletal and connective tissue disorders     
Back Pain  1  0/30 (0.00%)  0 2/30 (6.67%)  2
Nervous system disorders     
Sciatica  1  2/30 (6.67%)  2 0/30 (0.00%)  0
Renal and urinary disorders     
Incontinence  1  2/30 (6.67%)  2 0/30 (0.00%)  0
Reproductive system and breast disorders     
Menorrhagia  1  2/30 (6.67%)  2 3/30 (10.00%)  3
Pelvic Pain  1  4/30 (13.33%)  4 1/30 (3.33%)  1
Vaginal Exfoliation  1  2/30 (6.67%)  2 4/30 (13.33%)  4
Vaginal discharge  1  2/30 (6.67%)  2 1/30 (3.33%)  1
Vascular disorders     
Haematoma  1  3/30 (10.00%)  3 4/30 (13.33%)  4
Hypertension  1  5/30 (16.67%)  5 6/30 (20.00%)  7
Vasospasm  1  3/30 (10.00%)  3 2/30 (6.67%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor can require changes to the communication to remove any confidential information or other proprietary information of Sponsor.
Results Point of Contact
Name/Title: Ana Becker / Sr. Clinical Program Manager
Organization: Boston Scientific
Phone: 651-581-4605
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00628901     History of Changes
Other Study ID Numbers: M9011
ONC-PM-022005
First Submitted: February 25, 2008
First Posted: March 5, 2008
Results First Submitted: June 13, 2011
Results First Posted: August 22, 2011
Last Update Posted: July 11, 2012