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

Primary Purpose

Menorrhagia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Genesys HTA
Sponsored by
Minerva Surgical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menorrhagia focused on measuring Menorrhagia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sharp Mary Birch
  • Christiana Hospital
  • Shelnutt Obstetrics and Gynecology
  • Health South Surgecenter of Louisville
  • Wayne State University Physician Group
  • Seven Hills OB GYN Associates
  • Complete Healthcare for Women
  • Associates in Women's Healthcare
  • Schuykill Medical Center South
  • Chattanooga Medical Research
  • State of Franklin Healthcare Associates
  • Associates in Obstetrics and Gynecology
  • Central Womens Care PA
  • Doreen Moser, DO
  • MacArthur OBGYN
  • Personalized Women's Healthcare
  • Ogden Clinic
  • Old Farm Obstetrics and Gynecology
  • Milwaukee ObGyn

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Genesys HTA

Arm Description

Genesys HTA Endometrial Ablation

Outcomes

Primary Outcome Measures

Burn Rate

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 1, 2010
Last Updated
March 24, 2021
Sponsor
Minerva Surgical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01197547
Brief Title
Registry Study of Genesys HTA for Treatment of Menorrhagia
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Minerva Surgical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menorrhagia
Keywords
Menorrhagia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1014 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Genesys HTA
Arm Type
Other
Arm Description
Genesys HTA Endometrial Ablation
Intervention Type
Device
Intervention Name(s)
Genesys HTA
Other Intervention Name(s)
Genesys HTA Endometrial Ablation
Intervention Description
Genesys HTA Endometrial Ablation
Primary Outcome Measure Information:
Title
Burn Rate
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Technical Malfunctions
Description
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.
Time Frame
Day 1
Title
Serious Adverse Device Effect (SADE)
Description
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.
Time Frame
Day 1

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Bowman, M.D.
Organizational Affiliation
Boston Scientific Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Sharp Mary Birch
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Shelnutt Obstetrics and Gynecology
City
Athens
State/Province
Georgia
ZIP/Postal Code
30606
Country
United States
Facility Name
Health South Surgecenter of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Wayne State University Physician Group
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Seven Hills OB GYN Associates
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45201
Country
United States
Facility Name
Complete Healthcare for Women
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Associates in Women's Healthcare
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19115
Country
United States
Facility Name
Schuykill Medical Center South
City
Pottsville
State/Province
Pennsylvania
ZIP/Postal Code
17901
Country
United States
Facility Name
Chattanooga Medical Research
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
State of Franklin Healthcare Associates
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Associates in Obstetrics and Gynecology
City
Bedford
State/Province
Texas
ZIP/Postal Code
76021
Country
United States
Facility Name
Central Womens Care PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Doreen Moser, DO
City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States
Facility Name
MacArthur OBGYN
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
Personalized Women's Healthcare
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Ogden Clinic
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Old Farm Obstetrics and Gynecology
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Milwaukee ObGyn
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53221
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Registry Study of Genesys HTA for Treatment of Menorrhagia

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