Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization compared to Embosphere for Symptomatic Relief from Uterine Fibroids

Withdrawn

Conditions: Uterine Fibroids
10038595

Registration Number: NL-OMON36953

Lead Sponsor: Celonova

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 35

Inclusion Criteria

-Pre-menopausal women age 30-50 years at time of enrollment.
-Heavy menstrual bleeding with or without pain and bulk related symptoms

Exclusion Criteria

Pregnant patient or intends to become.
Has HIV or other immunodeficient state
Already infarcted or calcified fibroids present.
Présence or suspicion of malignancy or infection

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary effectiveness endpoint for this clinical trial is the proportion of<br /><br>subjects who have success, defined as 50% menstrual blood loss (MBL) reduction<br /><br>or less than 80 ml of MBL per cycle, evaluated by the alkaline hematin (AH)<br /><br>method, at 12 months.<br /><br><br /><br>The primary safety endpoint is the frequency of treatment emergent adverse<br /><br>events. There will be no hypothesis test for this endpoint because the rates of<br /><br>treatment emergent adverse events for embolization are very small, ranging from<br /><br>0.04 - 0.2% in the literature.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>There are three secondary effectiveness endpoints for this study: 1) The<br /><br>proportion of subjects with at least 90% infarct of the uterine fibroid at 6<br /><br>months following treatment; 2) The impact of excessive bleeding of fibroids on<br /><br>quality of life will be assessed with the UFS QOL Questionnaire; And 3) The<br /><br>need for re-intervention with repeat embolization or other therapy for<br /><br>treatment failure assessed.<br /><br>The results over time of the Uterine Fibroid Symptom & Health Related Quality<br /><br>of Life questionnaire will be compared descriptively. The mean response to<br /><br>pivotal summary evaluations will be presented for each treatment group, and<br /><br>within treatment groups the results will be compared to baseline.</p><br>