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MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Software V4.2 Validation

2014-07-24 14:25:33 | BioPortfolio

Summary

The goal of this study is to validate the new ExAblate Application software V4.2 by developing additional data that shows the safety of this treatment. The ExAblate is intended to ablate uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have a uterine size of less than 24 weeks and not seeking treatment for reasons of improving fertility.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Uterine Fibroids

Intervention

ExAblate 2000

Location

University of California at San Diego
LaJolla
California
United States
92037

Status

Completed

Source

InSightec

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:25:33-0400

Clinical Trials [424 Associated Clinical Trials listed on BioPortfolio]

MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids

This is a prospective, nonrandomized, multi-center study to evaluate the safety and effectiveness of ExAblate in the treatment of uterine fibroids. All patients will be treated and then f...

Magnetic Resonance (MR) Guided Focused Ultrasound Surgery of Uterine Fibroids

The goal of this study is to develop additional long term data to evaluate the safety and effectiveness of this treatment. Indications for use for this system is: 'The ExAblate is intende...

Safety Trial of Magnetic Resonance (MR) Guided Focused Ultrasound Surgery (FUS) in Women With Uterine Fibroids Wishing to Pursue Pregnancy in the Future

The study objective is to develop data for the safety of pregnancies after thermal ablation of uterine fibroids by MR guided Focused Ultrasound using the Ex Ablate 2000 system.

Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids

The purpose of this observational, retrospective database study of patients with uterine fibroids is to compare the durability of symptom relief after uterus-conserving treatments for symp...

Efficacy Study of Vaginal Mifepristone to Treat Uterine Fibroids

The purpose of this study is to evaluate the effect of daily dosage of vaginally mifepristone on reduction of uterine fibroids size and the symptoms associated with uterine fibroids.

PubMed Articles [1300 Associated PubMed Articles listed on BioPortfolio]

Outcome of magnetic resonance-Guided focused ultrasound surgery (MRgFUS) for FIGO class 1 fibroids.

Intracavitary uterine fibroids and fibroids that distort the uterine cavity are associated with excessive vaginal bleeding and infertility. While intracavitary fibroids smaller than 4 cm are usually...

Predictive factor for volume reduction of uterine fibroids after short-term use of ulipristal acetate.

Ulipristal acetate (UPA) is a selective progesterone receptor modulator, which has been used to treat uterine fibroids. Many published reports about the outcomes indicate effective control of bleeding...

Proteomic profiling of human uterine fibroids reveals upregulation of the extracellular matrix protein periostin.

The central characteristics of uterine fibroid is excessive deposition of extracellular matrix (ECM), which contributes to fibroid growth and bulk-type symptoms. Despite this, very little is known abo...

Adverse obstetric outcomes in pregnant women with uterine fibroids in China: A multicenter survey involving 112,403 deliveries.

To estimate the association between uterine fibroids and adverse obstetric outcomes.

Ulipristal acetate for pre-operative management of uterine fibroids: Modeling outcomes and costs.

The aim of this study was to evaluate the pharmacoeconomic profile in Italy of preoperative treatment with ulipristal acetate at the dose of 5 mg/day for 13 weeks in comparison with placebo prior to...

Medical and Biotech [MESH] Definitions

Inflation of a balloon catheter within the uterine cavity to control UTERINE HEMORRHAGE.

Measurement or recording of contraction activity of the uterine muscle. It is used to determine progress of LABOR, OBSTETRIC and assess status of pregnancy. It is also used in conjunction with FETAL MONITORING to determine fetal response to stress of maternal uterine contractions.

Pathological processes of the UTERINE CERVIX.

Tumors or cancer of the UTERINE CERVIX.

Loss or destruction of the epithelial lining of the UTERINE CERVIX.

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