Registry Study of Genesys HTA for Treatment of Menorrhagia
NCT ID: NCT01197547
Last Updated: 2021-03-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1014 participants
INTERVENTIONAL
2010-11-30
2012-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Genesys HTA
Genesys HTA Endometrial Ablation
Genesys HTA
Genesys HTA Endometrial Ablation
Interventions
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Genesys HTA
Genesys HTA Endometrial Ablation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
18 Years
FEMALE
No
Sponsors
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Minerva Surgical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Bowman, M.D.
Role: STUDY_DIRECTOR
Boston Scientific Corporation
Locations
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Sharp Mary Birch
San Diego, California, United States
Christiana Hospital
Newark, Delaware, United States
Shelnutt Obstetrics and Gynecology
Athens, Georgia, United States
Health South Surgecenter of Louisville
Louisville, Kentucky, United States
Wayne State University Physician Group
Southfield, Michigan, United States
Seven Hills OB GYN Associates
Cincinnati, Ohio, United States
Complete Healthcare for Women
Columbus, Ohio, United States
Associates in Women's Healthcare
Philadelphia, Pennsylvania, United States
Schuykill Medical Center South
Pottsville, Pennsylvania, United States
Chattanooga Medical Research
Chattanooga, Tennessee, United States
State of Franklin Healthcare Associates
Johnson City, Tennessee, United States
Associates in Obstetrics and Gynecology
Bedford, Texas, United States
Central Womens Care PA
Dallas, Texas, United States
Doreen Moser, DO
Grapevine, Texas, United States
MacArthur OBGYN
Irving, Texas, United States
Personalized Women's Healthcare
Plano, Texas, United States
Ogden Clinic
Ogden, Utah, United States
Old Farm Obstetrics and Gynecology
Salt Lake City, Utah, United States
Milwaukee ObGyn
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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U8088
Identifier Type: -
Identifier Source: org_study_id
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