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Uterine Fibroids clinical trials

View clinical trials related to Uterine Fibroids.

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NCT ID: NCT01388907 Completed - Uterine Fibroids Clinical Trials

Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery

Start date: May 2006
Phase: Phase 4
Study type: Interventional

The purpose of this study was to evaluate clinically the efficacy of the PREVADH® Film in the prevention of adhesions in gynaecologic surgery, and to assess post-operative complications related to adhesions and pregnancy rate after myomectomy by open surgery.

NCT ID: NCT01377519 Completed - Uterine Fibroids Clinical Trials

Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids

PROMISe
Start date: June 2011
Phase: N/A
Study type: Interventional

This is a pilot randomized, blinded, placebo-controlled trial of a noninvasive, FDA approved treatment for uterine fibroids called MR Guided Focused Ultrasound (MRgFUS). Our hypothesis is that MRgFUS provides superior relief of fibroid symptoms compared with the placebo, a sham MRgFUS treatment. The investigators will recruit 20 premenopausal women with symptomatic uterine fibroids to participate in the trial. Participants will be randomly assigned in a 2:1 ratio to the active treatment arm (MRgFUS) versus the sham MRgFUS treatment. Participants will remain blinded to their group assignment for 3 months. After 3 months, participants will be told their treatment group and those assigned to the sham group will be offered complimentary MRgFUS if they desire it. Women will be excluded if they are inappropriate candidates for a 3 month delay in fibroid treatment, such as those with significant anemia. The investigators will assess the change from baseline to 1 and 3 months after treatment in fibroid symptoms, quality of life, fibroid volume measured by MRI, and hematocrit.

NCT ID: NCT01369758 Active, not recruiting - Uterine Fibroids Clinical Trials

MyoSure Hysteroscopic Tissue Removal System Registry Study

Start date: November 2010
Phase: Phase 4
Study type: Interventional

The objective of this study is to demonstrate the safety and effectiveness of community gynecologist initiated treatment of intra-uterine polyps and submucosal fibroids with the MyoSure Hysteroscopic Tissue Removal System in a significantly sized patient population.

NCT ID: NCT01328067 Withdrawn - Bleeding Clinical Trials

Study to Evaluate the Safety and Effectiveness of MRgFUS Compared With Myomectomy for the Treatment of Uterine Fibroids

Start date: June 2011
Phase: N/A
Study type: Interventional

The objective of this trial is to evaluate the safety and efficacy of ExAblate for the treatment of uterine fibroids. Women, seeking treatment for symptomatic uterine leiomyomata will be eligible for the study.Women who agree to participate will sign an informed consent and will be randomized to ExAblate treatment or myomectomy. All patients will be followed through the 36 month visit. Follow-up visits/telephone calls will be completed at 1 week, 2 weeks, 6 weeks, 3 months, 6, 12, 18, 24 and 36 months post treatment. Patients will be evaluated by assessing their overall physical and mental health as well as for device/procedure related adverse events.

NCT ID: NCT01285960 Completed - Uterine Fibroids Clinical Trials

ExAblate UF V2 System for the Treatment of Symptomatic Uterine Fibroids

Start date: May 2012
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT01252069 Completed - Uterine Fibroids Clinical Trials

PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study)

Start date: January 2011
Phase: Phase 3
Study type: Interventional

This is the long-term extension of a phase III, efficacy and safety open-label (protocol PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the administration of progestin or placebo tablets after end of PGL4001 treatment. This extension study consists of three periods of 3 months open-label PGL4001 treatment, each followed by ten days of double-blind treatment with progestin or placebo and then a period without treatment.

NCT ID: NCT01229826 Completed - Uterine Fibroids Clinical Trials

Magnetic Resonance Elastography (MRE) of Uterine Fibroids

MRE
Start date: October 2010
Phase: N/A
Study type: Observational

The purpose of this study is to gain additional information regarding use of Magnetic Resonance Elastography (MRE) for uterine fibroid characterization. In this study, the investigators will use a new noninvasive technology, MRE, to further characterize the elastic properties of the uterine fibroids. To date, very little is known concerning how the tissue composition of the uterine fibroid may affect its treatment with Magnetic Resonance Guided Focused Ultrasound (MRgFUS). In this study, the investigators will use a new noninvasive technology, magnetic resonance elastography (MRE), to further characterize the elastic properties of the uterine fibroids. This information will be gathered during routine magnetic resonance imaging for symptomatic uterine fibroids. It is known that some fibroids with increased T2-signal on Magnetic Resonance Imaging(MRI) can be more difficult to treat. This information will be gathered during routine magnetic resonance imaging for symptomatic uterine fibroids.

NCT ID: NCT01226290 Terminated - Uterine Fibroids Clinical Trials

Fibroid Ablation Study

FAST-EU
Start date: January 2011
Phase: N/A
Study type: Interventional

The primary objective of this study is to establish the effectiveness and confirm the safety of the VizAblate System in ablating symptomatic uterine fibroids.

NCT ID: NCT01156857 Completed - Uterine Fibroids Clinical Trials

PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

PEARLIII
Start date: July 2010
Phase: Phase 3
Study type: Interventional

This is a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once daily for 3 months, blinded towards the administration of progestin or placebo after end of PGL4001 treatment.

NCT ID: NCT01152112 Active, not recruiting - Uterine Fibroids Clinical Trials

HOME Study: Hysteroscopic Office Myomectomy Evaluation

HOME
Start date: June 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate safety and effectiveness of the MyoSure Tissue Removal System when used by community gynecologists in an office setting for the treatment of patients with symptomatic intrauterine polyps and submucosal fibroids.