Registry Study of Genesys HTA for Treatment of Menorrhagia (Genesys HTA)

March 24, 2021 updated by: Minerva Surgical, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1014

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Diego, California, United States, 92123
        • Sharp Mary Birch
    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Hospital
    • Georgia
      • Athens, Georgia, United States, 30606
        • Shelnutt Obstetrics and Gynecology
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Health South Surgecenter of Louisville
    • Michigan
      • Southfield, Michigan, United States, 48034
        • Wayne State University Physician Group
    • Ohio
      • Cincinnati, Ohio, United States, 45201
        • Seven Hills OB GYN Associates
      • Columbus, Ohio, United States, 43213
        • Complete Healthcare For Women
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19115
        • Associates in Women's Healthcare
      • Pottsville, Pennsylvania, United States, 17901
        • Schuykill Medical Center South
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Medical Research
      • Johnson City, Tennessee, United States, 37604
        • State of Franklin Healthcare Associates
    • Texas
      • Bedford, Texas, United States, 76021
        • Associates in Obstetrics and Gynecology
      • Dallas, Texas, United States, 75231
        • Central Womens Care PA
      • Grapevine, Texas, United States, 76051
        • Doreen Moser, DO
      • Irving, Texas, United States, 75062
        • MacArthur OBGYN
      • Plano, Texas, United States, 75093
        • Personalized Women's Healthcare
    • Utah
      • Ogden, Utah, United States, 84403
        • Ogden Clinic
      • Salt Lake City, Utah, United States, 84107
        • Old Farm Obstetrics and Gynecology
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53221
        • Milwaukee ObGyn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Genesys HTA
Genesys HTA Endometrial Ablation
Genesys HTA Endometrial Ablation
Other Names:
  • Genesys HTA Endometrial Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Burn Rate
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical Malfunctions
Time Frame: Day 1
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
Serious Adverse Device Effect (SADE)
Time Frame: Day 1
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Thomas Bowman, M.D., Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

September 1, 2010

First Submitted That Met QC Criteria

September 8, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Actual)

March 26, 2021

Last Update Submitted That Met QC Criteria

March 24, 2021

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • U8088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Menorrhagia

Clinical Trials on Genesys HTA

Subscribe