Trials / Recruiting
RecruitingNCT05386615
Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- InSightec · Industry
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Body System - Functional | MR-Guided Focused Ultrasound |
Timeline
- Start date
- 2016-02-16
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2022-05-23
- Last updated
- 2025-04-30
Locations
6 sites across 2 countries: United States, China
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05386615. Inclusion in this directory is not an endorsement.