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

Completed

• Conditions: Contraception; Menorrhagia
• Interventions: Device: ESS305 (Essure, BAY1454032); Procedure: NovaSure

• Registration Number: NCT01740687
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

This study has previously been posted by Conceptus, Inc. After acquiring Conceptus, Inc., Bayer is now the sponsor of the trial.

Study Timeline

• Study Start: 2012-11-13
• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-11-30
• Study First Posted: 2012-12-04
• Primary Completion: 2021-05-17
• Study Completion: 2021-06-14
• Results First Submitted: 2022-05-06
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-03
• Last Update Submitted: 2023-02-03
• Results First Posted: 2023-02-06
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 211

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Essure+NovaSure	NovaSure	The group of women relying on Essure micro-inserts for permanent birth control when NovaSure is performed following a successful Essure Confirmation Test
Essure+NovaSure	ESS305 (Essure, BAY1454032)	The group of women relying on Essure micro-inserts for permanent birth control when NovaSure is performed following a successful Essure Confirmation Test

Primary Outcome Measures

Name	Time	Method
Number of Pregnancies at 3-year Time Point (3-year Pregnancy Rate)	3 years after NovaSure Endometrial Ablation procedure
Number of Pregnancies at 1-year Time Point (1-year Pregnancy Rate)	1 year after NovaSure Endometrial Ablation procedure

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Events (AEs) When NovaSure Endometrial Ablation Was Performed in the Presence of Essure Inserts	After 3-year follow-up	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.