Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids
ConditionUterine Fibroid
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorInSightec
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- Eligibility is as per the symptomatic fibroids device indication. - All registry-consented patients following the treatment of their fibroid(s) with the Exablate system.
Disqualifiers
None
Trial population
pre- and peri- menopausal women with Uterine Fibroids
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Body System - Functional
DeviceMR-Guided Focused Ultrasound
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Exablate1 intervention
Trial outcomes
Primary outcomes
1
Occurrence of adverse events
All adverse events and/or serious adverse events will be documented and reported according to protocol.
Time frame
Through study completion, an average of 2 years. Source ClinicalTrials.gov