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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01197547
Other study ID # U8088
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2010
Est. completion date August 2012

Study information

Verified date April 2017
Source Minerva Surgical, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1014
Est. completion date August 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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: 1. The subject is pregnant or wants to be pregnant in the future 2. The subject has known or suspected endometrial carcinoma or premalignant change of the endometrium, such as adenomatous hyperplasia 3. The subject has active pelvic inflammatory disease or pyosalpinx 4. The subject has hydrosalpinx 5. The subject in whom a tight cervical seal cannot be established and maintained around the procedure sheath 6. 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 7. The subject has an intrauterine device in place 8. The subject has an active genital or urinary tract infection (e.g. cervicitis, endometritis, vaginitis, cystitis, etc.) at the time of treatment

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Genesys HTA
Genesys HTA Endometrial Ablation

Locations

Country Name City State
United States Shelnutt Obstetrics and Gynecology Athens Georgia
United States Associates in Obstetrics and Gynecology Bedford Texas
United States Chattanooga Medical Research Chattanooga Tennessee
United States Seven Hills OB GYN Associates Cincinnati Ohio
United States Complete Healthcare for Women Columbus Ohio
United States Central Womens Care PA Dallas Texas
United States Doreen Moser, DO Grapevine Texas
United States MacArthur OBGYN Irving Texas
United States State of Franklin Healthcare Associates Johnson City Tennessee
United States Health South Surgecenter of Louisville Louisville Kentucky
United States Milwaukee ObGyn Milwaukee Wisconsin
United States Christiana Hospital Newark Delaware
United States Ogden Clinic Ogden Utah
United States Associates in Women's Healthcare Philadelphia Pennsylvania
United States Personalized Women's Healthcare Plano Texas
United States Schuykill Medical Center South Pottsville Pennsylvania
United States Old Farm Obstetrics and Gynecology Salt Lake City Utah
United States Sharp Mary Birch San Diego California
United States Wayne State University Physician Group Southfield Michigan

Sponsors (1)

Lead Sponsor Collaborator
Minerva Surgical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Burn Rate Day 1
Secondary Technical Malfunctions A secondary endpoint of the Genesys HTA Post Approval Study is to assess technical complaints (i.e. disposable and hardware issues). Technical complaints are issues related to system components encountered during the procedure such as error messages, problems with the connection, power, early incomplete procedure terminations, or display/user interface, or damage to the unit. Day 1
Secondary Serious Adverse Device Effect (SADE) A secondary endpoint of the Genesys HTA Post Approval Study is to assess Serious Adverse Device Effects. Per the approved protocol, an SADE is an adverse device effect resulting in any of the consequences characteristic of a serious adverse event, or that might have led to any of these consequences if suitable action had not been taken or intervention had not been made, or if circumstances had been less opportune. Day 1
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