Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Uterine Fibroid
- Sponsor
- InSightec
- Enrollment
- 200
- Locations
- 6
- Primary Endpoint
- Occurrence of adverse events
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The goal of this Registry Study is to capture clinical pregnancy outcomes and fibroid treatment background data for any subject post-Exablate treatment for their symptomatic fibroids.
Detailed Description
This is an observational study only for all consented subjects who undergo an Exablate treatment. The Exablate procedure is a commercial treatment. The objective of this registry is to collect data about the effect of Exablate treatment on potential pregnancy occurrences in this population for two years post-treatment for purposes of labeling updates and overall safety data collection.
Investigators
Eligibility Criteria
Inclusion Criteria
- •- Eligibility is as per the symptomatic fibroids device indication. - All registry-consented patients following the treatment of their fibroid(s) with the Exablate system.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Occurrence of adverse events
Time Frame: Through study completion, an average of 2 years.
All adverse events and/or serious adverse events will be documented and reported according to protocol.