Embozene Microspheres for Uterine Fibroid Embolization (UFE)

NCT01675011 | Terminated Results DMC

• 1 other identifier: 2010-001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

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.

Conditions

Uterine Fibroids

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  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.

  12 Months post study procedure

Study Arms (2)

Embozene® Microspheres

EXPERIMENTAL

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

Embosphere®

ACTIVE COMPARATOR

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®

Interventions

Embozene® Microspheres DEVICE

Embozene® Microspheres

Embosphere® DEVICE

Embosphere®

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (2)

Albany Medical Center

Albany, New York, United States

Location

North Shore LIJ Medical Center

New Hyde Park, New York, United States

Location

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Limitations and Caveats

The trial was terminated early due to insufficient enrollment, therefore formal statistical analyses were not possible.

Results Point of Contact

• Title: Anastasia Becker - Director of Clinical Trials
• Organization: Boston Scientific

Ana.Becker@bsci.com

763-494-2170

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2012
• First Posted: August 29, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 11, 2016
• Results First Posted: February 12, 2015

Record last verified: 2016-02

Locations

US (2)