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

NCT ID: NCT05386615

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-16

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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Uterine Fibroid

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Exablate

Observational study of Exablate treatment.

Body System - Functional

Intervention Type DEVICE

MR-Guided Focused Ultrasound

Interventions

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Body System - Functional

MR-Guided Focused Ultrasound

Intervention Type DEVICE

Eligibility Criteria

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Inclusion 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

Exclusion Criteria: -
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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InSightec

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UCLA

Los Angeles, California, United States

Site Status RECRUITING

Stanford University

Stanford, California, United States

Site Status RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Huashan Hospital Affiliated to Fudan University

Shanghai, , China

Site Status ACTIVE_NOT_RECRUITING

Shanghai No. 1 Hospital

Shanghai, , China

Site Status RECRUITING

Shanghai No.1 Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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United States China

Central Contacts

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Nadir Alikacem

Role: CONTACT

+12146302000

Facility Contacts

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Polly Kay, RN, CCRP

Role: primary

310-794-0376

Caroline Huang

Role: primary

650-725-6409

Brittany Yaklich

Role: primary

507-538-7765

Han Wang, MD

Role: primary

+86 181 2128 9109

Na Tang

Role: primary

18901807566

Other Identifiers

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UF036

Identifier Type: -

Identifier Source: org_study_id

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