Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids

• Sponsor: InSightec (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05386615
• Collaborator: (none)
• Enrollment: 200
• Locations: 4
• Anticipated Duration (Months): 94.5
• Patients Per Site: 50
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Fibroid	Device: Body System - Functional

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.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 200 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids
• Actual Study Start Date: Feb 16, 2016
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Exablate Observational study of Exablate treatment.	Device: Body System - Functional; MR-Guided Focused Ultrasound

Outcome Measures

Primary Outcome Measures

1. Occurrence of adverse events [Through study completion, an average of 2 years.]

   All adverse events and/or serious adverse events will be documented and reported according to protocol.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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: -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA	Los Angeles	California	United States	90095
2	Stanford University	Stanford	California	United States	94305
3	Mayo Clinic	Rochester	Minnesota	United States	55905
4	Shanghai Jiaotong University No.1 Hospital	Shanghai	HongKou District	China	200080

Sponsors and Collaborators

• InSightec

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: InSightec
• ClinicalTrials.gov Identifier: NCT05386615
• Other Study ID Numbers: UF036
• First Posted: May 23, 2022
• Last Update Posted: May 23, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by InSightec: Uterine Fibroids; Exablate
• Additional relevant MeSH terms: Leiomyoma; Myofibroma

Study Results

No Results Posted as of May 23, 2022