A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test
NCT ID: NCT01740687
Last Updated: 2023-02-06
Study Results
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View full resultsBasic Information
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COMPLETED
211 participants
OBSERVATIONAL
2012-11-13
2021-06-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Essure+NovaSure
The group of women relying on Essure micro-inserts for permanent birth control when NovaSure is performed following a successful Essure Confirmation Test
ESS305 (Essure, BAY1454032)
Essure Permanent Birth Control
NovaSure
Nova Sure Endometrial Ablation
Interventions
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ESS305 (Essure, BAY1454032)
Essure Permanent Birth Control
NovaSure
Nova Sure Endometrial Ablation
Eligibility Criteria
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Inclusion Criteria
* Women who are relying on the Essure micro-inserts for permanent contraception following a successful Essure Confirmation Test (as applicable to the Post Approval Study)
* Women willing to accept the risk of pregnancy while relying on the Essure micro-inserts for prevention of pregnancy following a NovaSure ablation procedure for menorrhagia
Exclusion Criteria
* Women who present with any other medical complaints, conditions or symptoms unrelated to the Essure System and/or subsequent NovaSure EA including, but not limited to:
* Gynecological co-morbidities (e.g., pelvic infection, cervicitis, undiagnosed vaginal bleeding, endometrial cancer, myomas, and polyps)
* Reproductive tract anatomical variants and/or pathology which could make the subject unsuitable for the Essure and/or NovaSure transcervical procedures
* Women currently wearing an intrauterine device and unwilling to have it removed before NovaSure
21 Years
50 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Aurora, Colorado, United States
Ocala, Florida, United States
Decatur, Illinois, United States
Fort Wayne, Indiana, United States
Newburgh, Indiana, United States
Easton, Maryland, United States
Grand Blanc, Michigan, United States
Maplewood, Minnesota, United States
Las Vegas, Nevada, United States
Neptune City, New Jersey, United States
Winston-Salem, North Carolina, United States
Englewood, Ohio, United States
Mason, Ohio, United States
Pottstown, Pennsylvania, United States
Nashville, Tennessee, United States
Norfolk, Virginia, United States
Spokane, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here to find results for studies related to Bayer Healthcare products.
Other Identifiers
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16975
Identifier Type: -
Identifier Source: org_study_id
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