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Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization

NCT02884960 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2016-09-01

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and effectiveness of Embozene Microspheres compared with Embosphere Microspheres for the treatment of symptomatic uterine fibroids. A total of 118 patents with symptomatic uterine fibroids will be enrolled at 6 sites. Symptom severity, health-related quality of life, and the appearance of the fibroids will be assessed prior to treatment. Patients will then undergo the uterine fibroid embolization procedure with either Embosphere Microspheres or Embozene Microspheres, which will be randomly assigned. Clinical outcomes will be assessed 1 month, 3 months, 6 months and 12 months after the procedure, and imaging outcomes will be obtained 3 months after the procedure.

Conditions

  • Uterine Fibroids

Interventions

PROCEDURE

Uterine Fibroid Embolization

This procedure involves the administration of the study device into the uterine arteries to block the flow of blood in these vessels. This deprives fibroid tumors within the uterus of their blood flow, which can cause the tumors to die. This in turn can lead to the relief of symptoms associated with fibroids.

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Gary Siskin, MD

    lead OTHER

Principal Investigators

  • Gary Siskin, MD · Community Care Physicians

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-10-31
Completion
2018-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02884960 on ClinicalTrials.gov