Tailored Radiofrequency Ablation of Uterine Myomas

Status Completed

Clinical Trial Summary

To perform the use of radiofrequency myolysis (RFM) for the treatment of intra-uterine fibroids through less invasive access by combining trans-vaginal ultrasound, hysteroscopy and laparoscopy

Clinical Trial Description

Given that the RF ablation of solid tumors of the liver and other organs is successfully used as a usual approach, the investigators have decided to transfer this technology to an original treatment of uterine fibroids. The access to each individual fibroid was determined considering passage of the needle towards its centre through only compromised tissue and by the shortest possible route by combining trans-vaginal ultrasound, hysteroscopy and laparoscopy. To optimize radiofrequency myolysis, in fact, the investigators decided to improve the procedure by inserting three innovative elements: application of a virtual needle tracking system to follow the RF electrode during the ablation session, real-time monitoring of RF ablation by contrast-enhanced ultrasound and systematic biopsy of the lesions before electro-coagulation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04091529
Study type	Interventional
Source	International Evangelical Hospital
Contact
Status	Completed
Phase	N/A
Start date	March 1, 2017
Completion date	March 31, 2019

View Details

See also
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Withdrawn	`NCT04567589` - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada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Withdrawn	`NCT00768742` - Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study	N/A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