N/A
N=1,014
Registry Study of Genesys HTA for Treatment of Menorrhagia
Menorrhagia
Bottom Line
View on ClinicalTrials.gov: NCT01197547 ↗Enrolled (actual)
1,014
Serious AEs
0.1%
Results posted
May 2017
Primary outcome: Primary: Burn Rate — 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Genesys HTA (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Minerva Surgical, Inc.
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Burn Rate |
4 | — |
| SECONDARY Technical Malfunctions |
.6; 4.4; 3.5; .9; 0.0; 0.0 | — |
| SECONDARY Serious Adverse Device Effect (SADE) |
1; 1; 1 | — |
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 physician, into the uterus, where it will fill and circulate fluid that is warm enough to change the characteristics of the uterine lining. This is done with the anticipated result of improving menstrual bleeding symptoms.
The purpose of this FDA-mandated registry is to obtain clinical experience on the use the Genesys HTA™ system, under normal clinical conditions, and document its safety and technical reliability.
Eligibility Criteria
Inclusion Criteria
- Subject must meet the approved indication for use to be considered for this registry.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01197547). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.