Trial record 8 of 9 for: "Leiomyomatosis"

Previous Study | Return to List | Next Study

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

History of Changes

Results First Received: June 13, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single Blind (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

Participant Flow

Hide Participant Flow

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
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.

Participant Flow: Overall Study

	Contour SE Microspheres	Embosphere Microspheres
STARTED	30	30
COMPLETED	27	29
NOT COMPLETED	3	1

Baseline Characteristics

Hide Baseline Characteristics

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]

Age
[Units: Participants]

<=18 years

Between 18 and 65 years

>=65 years

Age
[Units: Years]
Mean (Standard Deviation)

43.9 (5)

41.7 (5.4)

42.8 (5.3)

Gender
[Units: Participants]

Female

Male

Ethnicity (NIH/OMB)
[Units: Participants]

Hispanic or Latino

Not Hispanic or Latino

Unknown or Not Reported

Race (NIH/OMB) ^[1]
[Units: Particpants]

American Indian or Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

More than one race

Unknown or Not Reported

^[1]	Two participants in the Embosphere group had missing values for Race.

Region of Enrollment
[Units: Participants]

United States

Previous or concurrent gynecological disease(s)
[Units: Partcipants]

# of participants with concurrent gyneco disease

# of participants without concurrent gyneco diseas

Fibroid Related Symptoms ^[1]
[Units: Particpants]

Abnormal Bleeding

Bulk/pressure

Pelvic Pain

Other

^[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 fibroid

2 fibroids

3 fibroids

4 fibroids

5 fibroids

6 fibroids

7-10 fibroids

>10 fibroids

Number of fibroids present less than 2 cm
[Units: Participants]

0 fibroids

1 fibroid

2 fibroids

3 fibroids

4 fibroids

5 fibroids

6 fibroids

7-10 fibroids

>10 fibroids

Type of fibroid present ^[1]
[Units: Participants]

Submucosal

Subserosal

Intramural

Transmural

Other, specify

Cannot determine

^[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

Diffuse

Cannot Determine

^[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

Presence of myometrial scar
[Units: Participants]

Yes

Assessment of myometrial perfusion
[Units: Participants]

Normal

Mildly Decreased

Moderately Decreased

Severly Decreased/Infarcted

Ovaries seen
[Units: Participants]

Yes

Adnexal Pathology ^[1]
[Units: Participants]

Endometrioma/Endometriosis

Cyst

Other

^[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

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 ]

Show Outcome Measure 1

2. Secondary:

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

Show Outcome Measure 2

3. Secondary:

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

Show Outcome Measure 3

4. Secondary:

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

Show Outcome Measure 4

5. Secondary:

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

Show Outcome Measure 5

6. Secondary:

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

Show Outcome Measure 6

7. Secondary:

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

Show Outcome Measure 7

8. Secondary:

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

Show Outcome Measure 8

9. Secondary:

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

Show Outcome Measure 9

10. Secondary:

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

Show Outcome Measure 10

11. Secondary:

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

Show Outcome Measure 11

12. Secondary:

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

Show Outcome Measure 12

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

Limitations and Caveats

Hide Limitations and Caveats

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
No text entered.

More Information

Hide More Information

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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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
e-mail: Ana.Becker@bsci.com

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

Shlansky-Goldberg RD, Rosen MA, Mondschein JI, Stavropoulos SW, Trerotola SO, Diaz-Cartelle J. Comparison of polyvinyl alcohol microspheres and tris-acryl gelatin microspheres for uterine fibroid embolization: results of a single-center randomized study. J Vasc Interv Radiol. 2014 Jun;25(6):823-32. doi: 10.1016/j.jvir.2014.03.009. Epub 2014 Apr 29.

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

To Top