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Uterine Fibroids clinical trials

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NCT ID: NCT01142791 Completed - Uterine Fibroids Clinical Trials

Safety Study of ExAblate for the Treatment of Uterine Fibroids

Start date: May 2010
Phase: N/A
Study type: Interventional

The objective of this Phase IV study is to evaluate the safety of the ExAblate treatment of uterine fibroids using the enhanced sonication techniques, based on the current commercially-approved treatment guidelines. Treatment may include up to 100% of individual fibroid volume, within established serosal and sacral treatment margins. The Enhanced sonication is one of the various sonication modes that may lead to increased thermal dose volume of each sonication without additional safety risks. This is an additional treatment tool available in the ExAblate system for the treatment of uterine fibroids. The safety profile of the Enhanced Sonication was investigated under an FDA-regulated IDE study. FDA granted approval of Enhanced Sonication with the requirement to perform a post-approval study to collect additional safety data when treating up to 100% of individual fibroid volume.

NCT ID: NCT01140555 Terminated - Uterine Fibroids Clinical Trials

A Pilot Study to Determine Optimal Procedure Steps to Obtain and Maintain Uterine Artery Occlusion With the D-UAO Device

Start date: April 2010
Phase: N/A
Study type: Interventional

This pilot study has a sequential design involving three groups to ensure appropriate development and evaluation of the optimal procedural steps of the D-UAO device and to confirm that those steps are reproducible in the hands of multiple surgeons.

NCT ID: NCT01092988 Completed - Pain Clinical Trials

A Clinical Study to Evaluate Safety of the ExAblate 2100 UF V2 System in the Treatment of Symptomatic Uterine Fibroids

Start date: March 2010
Phase: N/A
Study type: Interventional

The first magnetic resonance-guided focused ultrasound (MRgFUS) treatment of uterine fibroid using the ExAblate 2000 system was performed in 2001. Since then, more than 5000 treatments were done in more than 60 different hospitals around the world. The experience accumulated in this novel treatment was collected by InSightec and implemented into software and hardware updates, clinical tips and guidelines, all aimed to improve the clinical results and their durability, while maintaining a high level of safety. Based on extensive clinical experience and our internal research and development effort goals toward continuous improvement in ExAblate treatment safety and performance, limited changes have been made to the current ExAblate system. This modified ExAblate system version is designated as the ExAblate 2100 UF V2 system. The modifications are believed to improve system's friendliness to the user, without introducing new risks or other issues of safety of the device, and should not have any negative impact on the safety or technical efficacy of the treatments for patients.

NCT ID: NCT01069120 Terminated - Uterine Fibroids Clinical Trials

Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids

Start date: April 2009
Phase: Phase 3
Study type: Interventional

Safety and efficacy study of 25 and 50 mg doses of Proellex

NCT ID: NCT00995878 Completed - Uterine Fibroids Clinical Trials

The FIRSTT: Comparing MRgFUS(MR-guided Focused Ultrasound) Versus UAE (Uterine Artery Embolization)for Uterine Fibroids.

Start date: April 29, 2010
Phase: Phase 4
Study type: Interventional

The primary goal of this study is to compare the safety and effectiveness of two standard fibroid treatments: MRI guided ultrasound surgery (MRgFUS) and uterine artery embolization (UAE). Both treatments are approved by the Food and Drug Administration (FDA) for women who do not plan to become pregnant. A second goal of this study is to better understand which symptoms bother women with fibroids the most. Understanding and addressing the symptoms of clinically-significant uterine fibroids is important in order to optimize treatment outcomes and control health care costs. Women who are eligible to participate in the study, are randomized to one of two treatment arms (UAE or MRgFUS). Women in both arms will receive treatment but will not be able to choose which treatment she will receive. A comprehensive assessment of symptoms-including experienced pain- will take place at baseline, 6 weeks, and at 6, 12, 24, and 36 months following treatment with UAE and MRgFUS.

NCT ID: NCT00979342 Completed - Uterine Fibroids Clinical Trials

Comparative Sedation Study of the MyoSure Hysteroscopic Tissue Removal System

Start date: November 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to develop a recommended local anesthetic protocol and post-treatment pain management regimen, in order to assure patient comfort during office-based treatment with the MyoSure Hysteroscopic Tissue Removal Device. Subject self-reported pain scores (as rated on an 11 point scale) will be compared at multiple time intervals between all treatment groups.

NCT ID: NCT00958893 Terminated - Uterine Fibroids Clinical Trials

An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext

Start date: June 2008
Phase: Phase 2
Study type: Interventional

An open label, extension study for subjects completing the ZPU-003 Ext 1 study.

NCT ID: NCT00958334 Completed - Uterine Fibroids Clinical Trials

Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003

Start date: September 7, 2006
Phase: Phase 2
Study type: Interventional

ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258) to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study.

NCT ID: NCT00897897 Completed - Uterine Fibroids Clinical Trials

Therapeutic Magnetic Resonance Imaging (MRI)-Guided High Intensity Focused Ultrasound (HIFU) Ablation of Uterine Fibroids

Start date: April 2009
Phase: N/A
Study type: Interventional

This study is to confirm the safety and technical effectiveness of MRI guided High Intensity Focused Ultrasound (HIFU) in ablating uterine tissue associated with symptomatic leiomyomas. The importance of this therapy is that it offers a non-invasive, uterine sparing procedure for the treatment of uterine fibroids in pre- and peri- menopausal women. MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate fibroid tissue. The MRI system identifies the ultrasound path and monitors heat rise in the fibroid tissue. The goal of the study is to show treatment safety and technical effectiveness. MR-guided HIFU will be performed in patients who pass inclusion/exclusion criteria. Safety, quality of life, and imaging endpoints will be evaluated in all study patients. The goal of this study is to demonstrate that: 1. The safety profile is acceptable (safety) 2. Actual MR-HIFU ablated volumes (as measured with contrast enhanced MRI) match the intended volumes (technical effectiveness) 3. When intended, volumes greater than 20% of the fibroid volume can be successfully ablated (technical effectiveness) The investigators' hypothesis is that greater than 70% of fibroids will have concordance between intended lesion volume and actual lesion volume while maintaining an acceptable safety profile.

NCT ID: NCT00886873 Completed - Uterine Fibroids Clinical Trials

Mifepristone 10 or 5 mg for 6 Months to Treat Uterine Fibroids

Mifemyo_2
Start date: May 2008
Phase: Phase 2/Phase 3
Study type: Interventional

The objectives of this study are to estimate the efficacy and safety of the daily administration for 6 months of 5 mg versus 10 mg. A 6 month follow-up of subjects is carried out to estimate how the effects of mifepristone are kept in time. The hypothesis of this study is that both mifepristone doses reduce the volume of the myoma up to 50% in six months treatment.