ExAblate UF V2 System for the Treatment of Symptomatic Uterine Fibroids

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the safety and ablation efficacy of the ExAblate UF V2 System when treating symptomatic uterine fibroids.

The ExAblate System is a medical device that involves a focused ultrasound system and an MRI scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the targeted tissue. In this particular study, the targeted tissue is uterine fibroids. Each sonication is used to heat small spots in the fibroid much like a magnifying glass can be used to focus light to heat a spot. The heat created kills a portion of the fibroid with the goal of decreasing or eliminating uterine fibroid-related symptoms. Repeated sonications are performed until the entire fibroid is treated or the treated volume is determined to be appropriate.

The ExAblate system is commercially approved in the United States to treat symptomatic uterine fibroids.

The ExAblate UF V2 System is an experimental device and is being investigated in this study. While similar to the commercial system, the ExAblate UF V2 device includes the following major changes, among others, which are intended to improve device performance and safety:

- Up and down movement of the ultrasound transducer, in an attempt to improve fibroid treatment by moving the ultrasound focal point within the targeted fibroid.

- Ultrasound energy can be turned off for a specific area in an attempt to minimize amount of energy passing through sensitive areas of the body.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01285960
Study type	Interventional
Source	InSightec
Contact
Status	Completed
Phase	N/A
Start date	May 2012
Completion date	April 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01441635` - Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids	Phase 2
Completed	`NCT00958334` - Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003	Phase 2
Withdrawn	`NCT04567589` - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada
Recruiting	`NCT05078307` - Evaluation of a Hysteroscopic Method With Vaporization in the Hysteroscopic Treatment of Submucosal Uterine Fibroids	N/A
Recruiting	`NCT02283502` - Clinical Test of the MRgHIFU System on Uterine Fibroids	Phase 1
Completed	`NCT01631903` - Extension of Study ZPV-200	Phase 2
Completed	`NCT01739621` - Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200	Phase 2
Withdrawn	`NCT00768742` - Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study	N/A
Completed	`NCT00152256` - A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids	Phase 3
Not yet recruiting	`NCT03586947` - Association Between Vitamin D and the Risk of Uterine Fibroids	N/A
Completed	`NCT02925494` - An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids	Phase 3
Not yet recruiting	`NCT06055114` - Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age
Terminated	`NCT05026502` - A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules
Withdrawn	`NCT04567095` - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Patients in Canada
Withdrawn	`NCT03699176` - Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids	Phase 3
Not yet recruiting	`NCT02884960` - Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization	N/A
Completed	`NCT02472184` - Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy	N/A
Completed	`NCT01452659` - Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids	Phase 2
Terminated	`NCT01555073` - Preemptive Analgesia Following Uterine Artery Embolization	Phase 4
Completed	`NCT01229826` - Magnetic Resonance Elastography (MRE) of Uterine Fibroids	N/A