Trial Condition(s):

Contraception, Menorrhagia

A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test (ESS-NSPAS)

Bayer Identifier:

16975

ClinicalTrials.gov Identifier:

NCT01740687

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

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.

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 an intrauterine device and unwilling to have it removed before NovaSure

Trial Summary

Enrollment Goal
211
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Essure (ESS305, BAY1454032)
Accepts Healthy Volunteers
No

Where to Participate

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Investigative Site

Pottstown, United States, 19464

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Nashville, United States, 37232

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Newburgh, United States, 47630

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Easton, United States, 21601

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Decatur, United States, 62526

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Fort Wayne, United States, 46825

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Spokane, United States, 99204

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Grand Blanc, United States, 48439

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Las Vegas, United States, 89102

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Aurora, United States, 80045

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Ocala, United States, 34471

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Winston-Salem, United States, 27103

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Mason, United States, 45040

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Maplewood, United States, 55109

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Englewood, United States, 45322

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Norfolk, United States, 23507

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Investigative Site

Neptune, United States, 07753

Trial Design