Uterine Fibroids Clinical Trial
Official title:
The Trust (Treatment Results of Uterine Sparing Technologies) Study
This Post Market study is being conducted to compare the direct and indirect cost of three approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of symptomatic uterine fibroids.
Uterine fibroids are the most common pelvic neoplasms in women; they severely impact quality of life and are the leading indication for hysterectomy. Hysterectomy is the definitive treatment for myomas; however, many patients seek alternative uterine-sparing therapy and desire to conserve their fertility. Myomectomy is a much-reported surgical option for women with symptomatic fibroids and, until recently, the abdominal approach has been the approach of choice for most surgeons. Over time, patients have requested less invasive procedures and minimally invasive, laparoscopic options are becoming more popular among patients and their gynecologists. Standard surgical and interventional treatments for uterine fibroids are costly to society and to the health care system. New technologies such as GFA may offer a low-cost alternative to the standard treatments for symptomatic uterine fibroids in women who desire uterine conservation. This study seeks to evaluate those cost differences between three available uterine-sparing techniques and to explore the qualitative outcomes such as symptom severity, health related quality of life, and overall treatment effect. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01441635 -
Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids
|
Phase 2 | |
Completed |
NCT00958334 -
Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003
|
Phase 2 | |
Withdrawn |
NCT04567589 -
A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada
|
||
Recruiting |
NCT05078307 -
Evaluation of a Hysteroscopic Method With Vaporization in the Hysteroscopic Treatment of Submucosal Uterine Fibroids
|
N/A | |
Recruiting |
NCT02283502 -
Clinical Test of the MRgHIFU System on Uterine Fibroids
|
Phase 1 | |
Completed |
NCT01739621 -
Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200
|
Phase 2 | |
Completed |
NCT01631903 -
Extension of Study ZPV-200
|
Phase 2 | |
Withdrawn |
NCT00768742 -
Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study
|
N/A | |
Completed |
NCT00152256 -
A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids
|
Phase 3 | |
Not yet recruiting |
NCT03586947 -
Association Between Vitamin D and the Risk of Uterine Fibroids
|
N/A | |
Completed |
NCT02925494 -
An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
|
Phase 3 | |
Not yet recruiting |
NCT06055114 -
Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age
|
||
Terminated |
NCT05026502 -
A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules
|
||
Withdrawn |
NCT04567095 -
A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Patients in Canada
|
||
Withdrawn |
NCT03699176 -
Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
|
Phase 3 | |
Not yet recruiting |
NCT02884960 -
Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization
|
N/A | |
Completed |
NCT02472184 -
Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy
|
N/A | |
Completed |
NCT01452659 -
Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids
|
Phase 2 | |
Terminated |
NCT01555073 -
Preemptive Analgesia Following Uterine Artery Embolization
|
Phase 4 | |
Completed |
NCT01229826 -
Magnetic Resonance Elastography (MRE) of Uterine Fibroids
|
N/A |