Registry Study of Genesys HTA for Treatment of Menorrhagia

Menorrhagia Clinical Trial

— Genesys HTA  

Official title:

Genesys HTA Post Approval Registry A Multi-center, Single-arm, Prospective Registry of the Genesys HTA System for the Treatment of Menorrhagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197547
• Other study ID #: U8088
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Menorrhagia

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