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Uterine Fibroids clinical trials

View clinical trials related to Uterine Fibroids.

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NCT ID: NCT02884960 Not yet recruiting - Uterine Fibroids Clinical Trials

Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization

Start date: October 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of Embozene Microspheres compared with Embosphere Microspheres for the treatment of symptomatic uterine fibroids. A total of 118 patents with symptomatic uterine fibroids will be enrolled at 6 sites. Symptom severity, health-related quality of life, and the appearance of the fibroids will be assessed prior to treatment. Patients will then undergo the uterine fibroid embolization procedure with either Embosphere Microspheres or Embozene Microspheres, which will be randomly assigned. Clinical outcomes will be assessed 1 month, 3 months, 6 months and 12 months after the procedure, and imaging outcomes will be obtained 3 months after the procedure.

NCT ID: NCT02844920 Completed - Uterine Fibroids Clinical Trials

Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids

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Start date: July 20, 2017
Phase:
Study type: Observational

This study is designed to observe the presence or absence of intrauterine adhesions at 6 weeks after treatment with the Sonata® System through hysteroscopic evaluation by third party readers.

NCT ID: NCT02835391 Completed - Cancer Clinical Trials

PerClot Compared to Usual Care in Gynaecology Procedures

Start date: November 2015
Phase: N/A
Study type: Interventional

This study is a post market, multi-centre, randomised study evaluating PerClot compared to usual care. PerClot is a CE marked device and is currently used as a haemostat in gynaecological surgery throughout Europe. The purpose of this study is to collect additional post market data on its use in this indication.

NCT ID: NCT02831556 Completed - Pregnancy Clinical Trials

Point of Care 3D Ultrasound for Various Applications: A Pilot Study

Start date: July 2016
Phase:
Study type: Observational

Summary 1. Purpose and Objective: The purpose of this study is to test the feasibility of rapid acquisition of point of care 3D ultrasound in obtaining abdominal and/or pelvic images. The study will use a newly developed acquisition method and post-processing technique to create three dimensional image models of the abdomen and/or pelvis. 2. Study activities and population group. The study population will be a convenience sample of patients of any age presenting to the Emergency Department with complaints necessitating a clinical abdominal and/or pelvic imaging. The study intervention includes acquisition of research ultrasound images, which will not be used for clinical care, and comparison of these images with clinically obtained images. Other clinical data such as surgical and pathology reports will also be reviewed. 3.Data analysis and risk/safety issues. This is a pilot study intended to determine feasibility and to refine image reconstruction algorithms. Research images will be compared to clinical images. Comparison of research images with final diagnosis will also occur. The research intervention, an ultrasound exam, has no known safety risks. The only risk to subjects is loss of confidentiality. This study is observational, not interventional, because the experimental ultrasound will be performed in all subjects and will not be used in the clinical care of patients (consequently, will not have the opportunity to affect clinical outcomes). Experimental images will be reviewed after completion of clinical care and will not be provided to the clinicians caring for the subjects. The investigators are not measuring the effect of the ultrasound examination on the subjects' outcomes.

NCT ID: NCT02819609 Completed - Uterine Fibroids Clinical Trials

Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids

Start date: November 2014
Phase: N/A
Study type: Observational

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 symptomatic fibroids in terms of incidence of, and time to, new or recurrent symptoms and subsequent procedures and evaluate the effect stakeholder participation had on the research process.

NCT ID: NCT02811159 Terminated - Uterine Fibroids Clinical Trials

An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids

Start date: July 26, 2016
Phase: Phase 2
Study type: Interventional

To determine the safety of extended treatment with Proellex® in women who have successfully completed either study ZPV-201 [NCT02323646] or ZPU-203 [NCT02301897] and meet eligibility criteria.

NCT ID: NCT02748460 Active, not recruiting - Uterine Fibroids Clinical Trials

Non-interventional Study to Evaluate Long Term Safety, Prescription Management Patterns of Esmya in a Long Term Setting

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Start date: December 2015
Phase:
Study type: Observational

This is a multi-centre, multinational, prospective, non-interventional study in females with a diagnosis of moderate to severe uterine fibroids, and for whom a treatment with Esmya in a long term manner is planned, and in subjects who were previously exposed to UPA in the long term Phase III studies.

NCT ID: NCT02691494 Completed - Uterine Fibroids Clinical Trials

Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)

Start date: February 3, 2016
Phase: Phase 3
Study type: Interventional

This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

NCT ID: NCT02655237 Completed - Uterine Fibroids Clinical Trials

A Phase 3 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids

Start date: March 5, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of Relugolix (TAK-385) 40 mg administered orally once daily for 12 weeks, compared with leuprorelin injection (once every 4 weeks, 1.88 mg or 3.75 mg subcutaneously [SC]/time) in patients with uterine fibroids.

NCT ID: NCT02655224 Completed - Uterine Fibroids Clinical Trials

A Placebo-Controlled, Phase 3 Study of Relugolix (TAK-385) 40 mg in the Treatment of Pain Symptoms Associated With Uterine Fibroids

Start date: March 26, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of Relugolix (TAK-385) in patients having pain symptoms associated with uterine fibroids.