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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

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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

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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.

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PubMed Articles [1296 Associated PubMed Articles listed on BioPortfolio]

Uterine Fibroids and the Risk of Cardiovascular Disease in the Coronary Artery Risk Development in Young Adult Women's Study.

Uterine fibroids, the most common reproductive tract tumor in women, have been associated with hypertension and atherosclerotic cardiovascular disease (CVD). Prior studies of fibroids and CVD have exa...

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Minimally invasive therapies to treat symptoms of uterine fibroids can be effective alternatives to major surgery. Such modalities include pharmacologic agents, uterine artery embolization (UAE), MR g...

Burden, Prevalence, and Treatment of Uterine Fibroids: A Survey of US Women.

Most women will experience uterine fibroids by the age of 50, yet few data exist describing the overall patient experience with fibroids. The objective of this population-based survey was to character...

Reintervention Rates After Myomectomy, Endometrial Ablation, and Uterine Artery Embolization for Patients with Uterine Fibroids.

Women with uterine fibroids (UF) may undergo less invasive procedures than hysterectomy, including myomectomy, endometrial ablation (EA), and uterine artery embolization (UAE); however, long-term need...

Changes in sexuality during ulipristal acetate treatment in women with symptomatic uterine fibroids.

To evaluate changes in sexuality in women treated with Ulipristal acetate (UPA) due to symptomatic uterine fibroids.

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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