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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00628901
First received: February 25, 2008
Last updated: July 2, 2012
Last verified: July 2012
Results First Received: June 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Leiomyoma
Uterine Fibroids
Uterine Neoplasms
Menorrhagia
Leiomyomatosis
Interventions: Procedure: Uterine Fibroid Embolization (UFE)
Device: Contour SE™ Microspheres
Device: Embosphere® Microspheres

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Contour SE Microspheres 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
Embosphere Microspheres Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.

Participant Flow:   Overall Study
    Contour SE Microspheres   Embosphere Microspheres
STARTED   30   30 
COMPLETED   27   29 
NOT COMPLETED   3   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Contour SE Microspheres 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
Embosphere Microspheres Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Total Total of all reporting groups

Baseline Measures
   Contour SE Microspheres   Embosphere Microspheres   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   30   30   60 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.9  (5)   41.7  (5.4)   42.8  (5.3) 
Gender 
[Units: Participants]
     
Female   30   30   60 
Male   0   0   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   0   1   1 
Not Hispanic or Latino   21   18   39 
Unknown or Not Reported   9   11   20 
Race (NIH/OMB) [1] 
[Units: Particpants]
     
American Indian or Alaska Native   0   0   0 
Asian   2   0   2 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   21   20   41 
White   7   6   13 
More than one race   0   2   2 
Unknown or Not Reported   0   2   2 
[1] Two participants in the Embosphere group had missing values for Race.
Region of Enrollment 
[Units: Participants]
     
United States   30   30   60 
Previous or concurrent gynecological disease(s) 
[Units: Partcipants]
     
# of participants with concurrent gyneco disease   5   7   12 
# of participants without concurrent gyneco diseas   25   23   48 
Fibroid Related Symptoms [1] 
[Units: Particpants]
     
Abnormal Bleeding   28   27   55 
Bulk/pressure   20   25   45 
Pelvic Pain   22   23   45 
Other   8   10   18 
[1] 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 
[Units: Particpants]
     
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 
[Units: 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] 
[Units: 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] 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 
[Units: Cm^3]
Mean (Standard Deviation)
 203.3  (275.1)   141.1  (179.6)   172.2  (232.5) 
Uterine Volume 
[Units: Cm^3]
Mean (Standard Deviation)
 1536.7  (937.3)   1491.6  (1456.5)   1514.2  (1214.5) 
Maximal thickness of junctional zone 
[Units: Mm]
Mean (Standard Deviation)
 11.4  (6.6)   10.9  (7.9)   11.2  (7.2) 
Maximal thickness of the endometrium 
[Units: Mm]
Mean (Standard Deviation)
 7.3  (2.8)   8.9  (3.3)   8.1  (3.2) 
Minimal thickness of the myometrium 
[Units: Mm]
Mean (Standard Deviation)
 11.2  (5.1)   9.5  (4.2)   10.3  (4.7) 
Concomitant adenomyosis [1] 
[Units: Participants]
     
Focal   7   5   12 
Diffuse   2   2   4 
Cannot Determine   0   0   0 
[1]

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

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 
[Units: Participants]
     
Yes   0   1   1 
No   30   29   59 
Maximal Thickness of the myometrium 
[Units: Mm]
Mean (Standard Deviation)
 26.8  (8.1)   25.0  (7.4)   25.9  (7.8) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI)   [ Time Frame: 24-hours post study procedure ]

2.  Secondary:   Visual Analog Scale (VAS) Maximum Level of Nausea   [ Time Frame: 24 hours after study procedure ]

3.  Secondary:   Visual Analog Scale (VAS) Maximum Level of Pain   [ Time Frame: 24 hours after study procedure ]

4.  Secondary:   Fluoroscopy Time   [ Time Frame: During the study procedure (measured in minutes) ]

5.  Secondary:   Procedure Time   [ Time Frame: During the study procedure (measured in minutes) ]

6.  Secondary:   Any Adverse Events That the Participant Experienced   [ Time Frame: During the hospitalization stay post UFE ]

7.  Secondary:   Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score   [ Time Frame: Baseline ]

8.  Secondary:   Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score   [ Time Frame: 3-months ]

9.  Secondary:   Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score   [ Time Frame: 12 months ]

10.  Secondary:   Health Related Quality of Life (HRQL)Subscores   [ Time Frame: Baseline ]

11.  Secondary:   Health Related Quality of Life Subscores   [ Time Frame: 3 months ]

12.  Secondary:   Health Related Quality of Life Subscores   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only 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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only 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. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Ana Becker / Sr. Clinical Program Manager
Organization: Boston Scientific
phone: 651-581-4605
e-mail: Ana.Becker@bsci.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00628901     History of Changes
Other Study ID Numbers: M9011
ONC-PM-022005
Study First Received: February 25, 2008
Results First Received: June 13, 2011
Last Updated: July 2, 2012
Health Authority: United States: Institutional Review Board