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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01197547
First received: September 1, 2010
Last updated: April 7, 2017
Last verified: April 2017
  Purpose

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.


Condition Intervention
Menorrhagia Device: Genesys HTA

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Genesys HTA Post Approval Registry A Multi-center, Single-arm, Prospective Registry of the Genesys HTA System for the Treatment of Menorrhagia

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Burn Rate [ Time Frame: Day 1 ]

Secondary Outcome Measures:
  • 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.

  • 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.


Enrollment: 1014
Study Start Date: November 2010
Study Completion Date: August 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Genesys HTA
Genesys HTA Endometrial Ablation
Device: Genesys HTA
Genesys HTA Endometrial Ablation
Other Name: Genesys HTA Endometrial Ablation

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

    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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197547

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

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01197547     History of Changes
Other Study ID Numbers: U8088
Study First Received: September 1, 2010
Results First Received: June 7, 2016
Last Updated: April 7, 2017

Keywords provided by Boston Scientific Corporation:
Menorrhagia

Additional relevant MeSH terms:
Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes

ClinicalTrials.gov processed this record on September 20, 2017