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; 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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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
Number of Participants [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
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 ^[2] [units: particpants]
Abnormal Bleeding	28	27	55
Bulk/pressure	20	25	45
Pelvic Pain	22	23	45
Other	8	10	18
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 ^[3] [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
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 ^[4] [units: participants]
Focal	7	5	12
Diffuse	2	2	4
Cannot Determine	0	0	0
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 ^[5] [units: participants]
Endometrioma/Endometriosis	0	1	1
Cyst	3	2	5
Other	2	0	2
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

[1]	Two participants in the Embosphere group had missing values for Race.
[2]	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.
[3]	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.
[4]	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.
[5]	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.

Outcome Measures

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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 ]

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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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 ]

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9. Secondary:

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

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10. Secondary:

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

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11. Secondary:

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

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12. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.

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.

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

No publications provided

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

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