- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01197547
Registry Study of Genesys HTA for Treatment of Menorrhagia (Genesys HTA)
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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:
- 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
Study Plan
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:
|
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
Sponsor
Investigators
- Study Director: Thomas Bowman, M.D., Boston Scientific Corporation
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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
-
BayerCompletedIdiopathic MenorrhagiaCroatia, Saudi Arabia, Bulgaria, Jordan, Romania, Russian Federation, Turkey, United Arab Emirates, Kuwait, India, Pakistan, Serbia, Sri Lanka
-
BayerCompletedIdiopathic MenorrhagiaCroatia, South Africa, Colombia, Czech Republic, Jordan, Lebanon, Macedonia, The Former Yugoslav Republic of, Moldova, Republic of, Romania, Ukraine, Venezuela, Bosnia and Herzegovina, Syrian Arab Republic, Albania
-
Legacy Health SystemUnknownMenopause | Climacteric; Menorrhagia, MenopausalUnited States
-
Minerva Surgical, Inc.CompletedMenorrhagia Due to Benign CausesHungary
-
Minerva Surgical, Inc.CompletedMenorrhagia Due to Benign CausesMexico
-
Minerva Surgical, Inc.CompletedMenorrhagia Due to Benign CausesCanada
-
Faculty of Medicine, SousseCentre Hôpital Universitaire Farhat HachedCompletedMetrorrhagia | Hysterectomy | Heavy Menstrual Bleeding | Abnormal Uterine Bleeding | Menorrhagia; PostmenopausalTunisia
-
University of Sao PauloRecruitingCardiovascular Diseases | Arterial Hypertension | Postmenopausal; MenorrhagiaBrazil
-
BayerCompletedMenorrhagia, DysmenorrheaJapan
-
University of Sao PauloRecruitingMotor Activity | Physical Inactivity | Postmenopausal; MenorrhagiaBrazil
Clinical Trials on Genesys HTA
-
University Hospital, LilleAssociation HTA Vasc; CRESGE (Centre de Recherches Economiques Sociologiques... and other collaboratorsCompletedHigh Blood PressureFrance
-
Baylor Research InstituteTerminatedMenorrhagiaUnited States
-
Cnoga Medical Ltd.Carmel Medical CenterCompletedAccuracy of the SofTouch Device Measuring Blood Glucose and Other ParametersIsrael
-
Seattle Nuclear MedicineCompletedCancer | Bone MetastasesUnited States