A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation… (NCT01740687) | Clinical Trial Compass
CompletedNot Applicable
A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test
United States211 participantsStarted 2012-11-13
Plain-language summary
The purpose of the post approval study is to evaluate the effectiveness and safety of the Essure System when a NovaSure Endometrial Ablation procedure is performed following a successful Essure Confirmation Test.
Who can participate
Age range21 Years – 50 Years
SexFEMALE
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Inclusion Criteria:
* All inclusion criteria from the Essure Permanent Birth Control System Instructions for Use and/or the NovaSure Impedance Controlled Endometrial Ablation (EA) System Instructions for Use and Controller Operator's Manual will apply.
* Women experiencing menorrhagia due to benign causes
* 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:
* All exclusion criteria from the Essure Permanent Birth Control System Instructions for Use and/or the NovaSure Impedance Controlled Endometrial Ablation System Instructions for Use and Controller Operator's Manual will apply.
* Women who previously underwent a fallopian tube sterilization procedure (other than Essure placement)
* 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 …
What they're measuring
1
Number of Pregnancies at 1-year Time Point (1-year Pregnancy Rate)
Timeframe: 1 year after NovaSure Endometrial Ablation procedure
2
Number of Pregnancies at 3-year Time Point (3-year Pregnancy Rate)
Timeframe: 3 years after NovaSure Endometrial Ablation procedure