MyoSure Hysteroscopic Tissue Removal System Registry Study

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Between 500 and 600 subjects will be enrolled in a prospective, multi-center registry study. Approximately 100 of these cases will be completed in an office setting, with the remaining 400-500 cases completed in a hospital outpatient or ambulatory surgery center. Subjects will undergo a hysteroscopic tissue removal procedure to remove intrauterine polyps and submucosal fibroids. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01369758
Study type	Interventional
Source	Hologic, Inc.
Contact
Status	Active, not recruiting
Phase	Phase 4
Start date	November 2010
Completion date	November 2013

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Withdrawn	`NCT04567589` - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada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Withdrawn	`NCT00768742` - Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study	N/A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