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

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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Locations
Status
LocationsStatus
Locations

Investigative Site

Pottstown, United States, 19464

Status
Completed
 
Locations

Investigative Site

Nashville, United States, 37232

Status
Completed
 
Locations

Investigative Site

Newburgh, United States, 47630

Status
Completed
 
Locations

Investigative Site

Easton, United States, 21601

Status
Completed
 
Locations

Investigative Site

Decatur, United States, 62526

Status
Completed
 
Locations

Investigative Site

Fort Wayne, United States, 46825

Status
Completed
 
Locations

Investigative Site

Spokane, United States, 99204

Status
Completed
 
Locations

Investigative Site

Grand Blanc, United States, 48439

Status
Completed
 
Locations

Investigative Site

Las Vegas, United States, 89102

Status
Completed
 
Locations

Investigative Site

Aurora, United States, 80045

Status
Completed
 
Locations

Investigative Site

Ocala, United States, 34471

Status
Completed
 
Locations

Investigative Site

Winston-Salem, United States, 27103

Status
Completed
 
Locations

Investigative Site

Mason, United States, 45040

Status
Completed
 
Locations

Investigative Site

Maplewood, United States, 55109

Status
Completed
 
Locations

Investigative Site

Englewood, United States, 45322

Status
Completed
 
Locations

Investigative Site

Norfolk, United States, 23507

Status
Completed
 
Locations

Investigative Site

Neptune, United States, 07753

Status
Completed
 

Trial Design