NCT05386615

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
2 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Feb 2016Dec 2026

Study Start

First participant enrolled

February 16, 2016

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

10.9 years

First QC Date

May 18, 2022

Last Update Submit

April 29, 2025

Conditions

Uterine Fibroid

Keywords

Uterine FibroidsExablate

Outcome Measures

Primary Outcomes (1)

  • Occurrence of adverse events

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

    Through study completion, an average of 2 years.

Study Arms (1)

Exablate

Observational study of Exablate treatment.

Device: Body System - Functional

Interventions

Body System - FunctionalDEVICE

MR-Guided Focused Ultrasound

Exablate

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspre- and peri- menopausal women
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pre- and peri- menopausal women with Uterine Fibroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

UCLA

Los Angeles, California, 90095, United States

RECRUITING

Stanford University

Stanford, California, 94305, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Huashan Hospital Affiliated to Fudan University

Shanghai, China

ACTIVE NOT RECRUITING

Shanghai No. 1 Hospital

Shanghai, China

RECRUITING

Shanghai No.1 Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Nadir Alikacem

CONTACT

+12146302000nadira@insightec.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2022

First Posted

May 23, 2022

Study Start

February 16, 2016

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 30, 2025

Record last verified: 2025-04

Locations

CN(3)US(3)