Uterine Fibroids
Conditions
Interventions
All study participants will have the embolization procedure and the assignment
of the patients to this particular therapeutic strategy falls within current
practice of medicine.
The two treatment gr
Sponsors
Celonova
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. The primary safety endpoint is the frequency of treatment emergent adverse events. There will be no hypothesis test for this endpoint because the rates of treatment emergent adverse events for embolization are very small, ranging from 0.04 - 0.2% in the literature. | — |
Secondary
| Measure | Time frame |
|---|---|
| There are three secondary effectiveness endpoints for this study: 1) The proportion of subjects with at least 90% infarct of the uterine fibroid at 6 months following treatment; 2) The impact of excessive bleeding of fibroids on quality of life will be assessed with the UFS QOL Questionnaire; And 3) The need for re-intervention with repeat embolization or other therapy for treatment failure assessed. The results over time of the Uterine Fibroid Symptom & Health Related Quality of Life questionnaire will be compared descriptively. The mean response to pivotal summary evaluations will be presented for each treatment group, and within treatment groups the results will be compared to baseline. | — |
Countries
Netherlands
Outcome results
None listed