Uterine Fibroids Clinical Trial
Official title:
A Phase IV Clinical Study To Evaluate the Safety of MR-Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques
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.
n/a
| 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| Withdrawn |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| Withdrawn |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 | |
| Terminated |
NCT01555073 -
Preemptive Analgesia Following Uterine Artery Embolization
|
Phase 4 | |
| Completed |
NCT01452659 -
Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids
|
Phase 2 | |
| Completed |
NCT01229826 -
Magnetic Resonance Elastography (MRE) of Uterine Fibroids
|
N/A |