Study Completed

Contraception, Menorrhagia

Bayer Identifier:

16975

ClinicalTrials.gov Identifier:

NCT01740687

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

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.

Key Participants Requirements

Sex

Female

Age

21 - 50 Years

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

November 2012 - June 2021

Phase

N/A

Could I Receive a placebo

Products

Essure (ESS305, BAY1454032)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Pottstown, 19464, United States
Completed		Nashville, 37232, United States
Withdrawn		Columbus, 43214, United States
Completed		Newburgh, 47630, United States
Withdrawn		Phoenix, 85015, United States
Completed		Easton, 21601, United States
Withdrawn		Winston-Salem, 27103, United States
Withdrawn		Denver, 80220, United States
Completed		Decatur, 62526, United States
Completed		Fort Wayne, 46825, United States
Completed		Spokane, 99204, United States
Completed		Grand Blanc, 48439, United States
Completed		Las Vegas, 89102, United States
Withdrawn		Nashville, 37232, United States
Withdrawn		Columbus, 43231, United States
Completed		Aurora, 80045, United States
Withdrawn		Dayton, 45409, United States
Completed		Ocala, 34471, United States
Completed		Winston-Salem, 27103, United States
Completed		Mason, 45040, United States
Completed		Maplewood, 55109, United States
Completed		Newburgh, 47630, United States
Completed		Englewood, 45322, United States
Completed		Norfolk, 23507, United States
Completed		Neptune, 07753, United States

Primary Outcome

Number of pregnancies at 1-year time point (1-year pregnancy rate)
Time Frame:
1 year after NovaSure Endometrial Ablation procedure
Number of pregnancies at 3-year time point (3-year pregnancy rate)
Time Frame:
3 years after NovaSure Endometrial Ablation procedure

Secondary Outcome

Number of adverse events (AEs) when NovaSure endometrial ablation was performed in the presence of Essure inserts
An adverse event (AE) is any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom, or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. A serious adverse event (SAE) is classified as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is another serious or important medical event (IME) as judged by the investigator, or requires intervention to prevent permanent impairment of a body function or damage to a body structure.
Time Frame:
After 3-year follow-up

Trial design

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

Trial Type

Observational

Intervention Type

Device

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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