Embozene Microspheres for Uterine Fibroid Embolization (UFE)
Study Details
Study Description
Brief Summary
This is a randomized, prospective, multi-center study of 225 female subjects age 30-50 years with symptoms from uterine fibroids. All subjects will be followed for a total of thirty-six (36) months following uterine fibroid embolization.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Embozene® Microspheres Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink. |
Device: Embozene® Microspheres
|
| Active Comparator: Embosphere® Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink. |
Device: Embosphere®
|
Outcome Measures
Primary Outcome Measures
- Primary Endpoint [12 Months post study procedure]
The primary effectiveness endpoint for this clinical trial is the proportion of subjects who have success, defined as 50% menstrual blood loss (MBL) reduction or less than 80 ml of MBL per cycle, evaluated by the Alkaline Hematin (AH) method, at 12 months.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject is able to provide informed consent and must sign the Institutional Review Board approved Informed Consent Form.
-
Pre-menopausal women age 30-50 years at time of enrollment
-
Have been selected forUterine Fibroid Embolization (UFE) prior to entry to the study.
Exclusion Criteria:
-
Patient has a history of pelvic malignancy
-
Patient has an abnormal Pap smear within 12 months of the planned Uterine Fibroid Embolization procedure
-
Patient with coexisting condition that might explain abnormal bleeding (including endometrial hyperplasia and adenomyosis) or pelvic pain (including endometriosis and ovarian cysts).
-
Is at substantial risk for the need of organ transplantation, such as renal insufficiency.
-
Patient has evidence of current or recent pelvic inflammatory disease or uterine infection.
-
Patient with a severe contrast allergy or renal insufficiency that would represent a contradiction to the administration of iodine-based contrast agents.
-
Patients unable to comply with the follow-up requirements of the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Albany Medical Center | Albany | New York | United States | |
| 2 | North Shore LIJ Medical Center | New Hyde Park | New York | United States |
Sponsors and Collaborators
- Boston Scientific Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2010-001
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 11 patients screened and 4 randomized. |
| Arm/Group Title | Embozene® Microspheres | Embosphere® |
|---|---|---|
| Arm/Group Description | Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink. Embozene® Microspheres | Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink. Embosphere® |
| Period Title: Overall Study | ||
| STARTED | 3 | 1 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 3 | 1 |
Baseline Characteristics
| Arm/Group Title | Embozene® Microspheres | Embosphere® | Total |
|---|---|---|---|
| Arm/Group Description | Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink. Embozene® Microspheres | Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink. Embosphere® | Total of all reporting groups |
| Overall Participants | 3 | 1 | 4 |
| Age (years) [Mean (Full Range) ] | |||
| Mean (Full Range) [years] |
45
|
45
|
45
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
3
100%
|
1
100%
|
4
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
3
100%
|
1
100%
|
4
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
66.7%
|
1
100%
|
3
75%
|
| White |
1
33.3%
|
0
0%
|
1
25%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
3
100%
|
1
100%
|
4
100%
|
Outcome Measures
| Title | Primary Endpoint |
|---|---|
| Description | The primary effectiveness endpoint for this clinical trial is the proportion of subjects who have success, defined as 50% menstrual blood loss (MBL) reduction or less than 80 ml of MBL per cycle, evaluated by the Alkaline Hematin (AH) method, at 12 months. |
| Time Frame | 12 Months post study procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| The study was terminated due to inadequate enrollment; no patients completed the 12 month visit. |
| Arm/Group Title | Embozene® Microspheres | Embosphere® |
|---|---|---|
| Arm/Group Description | Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink. Embozene® Microspheres | Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink. Embosphere® |
| Measure Participants | 0 | 0 |
Adverse Events
| Time Frame | Day 0 through 6 months. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Embozene® Microspheres | Embosphere® | ||
| Arm/Group Description | Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink. Embozene® Microspheres | Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink. Embosphere® | ||
All Cause Mortality |
||||
| Embozene® Microspheres | Embosphere® | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Embozene® Microspheres | Embosphere® | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/3 (0%) | 0/1 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Embozene® Microspheres | Embosphere® | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/3 (0%) | 1/1 (100%) | ||
| Gastrointestinal disorders | ||||
| Constipation | 0/3 (0%) | 0 | 1/1 (100%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
| Name/Title | Anastasia Becker - Director of Clinical Trials |
|---|---|
| Organization | Boston Scientific |
| Phone | 763-494-2170 |
| Ana.Becker@bsci.com |
- 2010-001