Status:
COMPLETED
Registry Study of Genesys HTA for Treatment of Menorrhagia
Lead Sponsor:
Minerva Surgical, Inc.
Conditions:
Menorrhagia
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This is a clinical registry of an FDA approved device system called the Genesys Hydro ThermAblatorTM (HTA) system (Boston Scientific). The HTA system's intended use is to be inserted, by a trained phy...
Eligibility Criteria
Inclusion
- Subject must meet the approved indication for use to be considered for this registry.
Exclusion
- All subjects contraindicated for the treatment of the Genesys HTA System per the Directions for Use will be excluded:
- The subject is pregnant or wants to be pregnant in the future
- The subject has known or suspected endometrial carcinoma or premalignant change of the endometrium, such as adenomatous hyperplasia
- The subject has active pelvic inflammatory disease or pyosalpinx
- The subject has hydrosalpinx
- The subject in whom a tight cervical seal cannot be established and maintained around the procedure sheath
- The subject has an anatomical condition (e.g. history of previous classical cesarean section or transmural myomectomy) or pathologic condition (e.g. long term medical therapy) that could lead to weakening of the myometrium
- The subject has an intrauterine device in place
- The subject has an active genital or urinary tract infection (e.g. cervicitis, endometritis, vaginitis, cystitis, etc.) at the time of treatment
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
1014 Patients enrolled
Trial Details
Trial ID
NCT01197547
Start Date
November 1 2010
End Date
August 1 2012
Last Update
March 26 2021
Active Locations (19)
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1
Sharp Mary Birch
San Diego, California, United States, 92123
2
Christiana Hospital
Newark, Delaware, United States, 19718
3
Shelnutt Obstetrics and Gynecology
Athens, Georgia, United States, 30606
4
Health South Surgecenter of Louisville
Louisville, Kentucky, United States, 40207