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

Bayer

Status: Completed

Conditions: Contraception; Menorrhagia

Treatments: Procedure: NovaSure; Device: ESS305 (Essure, BAY1454032)

Study type: Observational

Funder types: Industry

Identifiers

NCT01740687

16975

Details and patient eligibility

About

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.

Full description

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

Enrollment: 211 patients

Sex: Female

Ages: 21 to 50 years old

Volunteers: No Healthy Volunteers

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 design

211 participants in 1 patient group

Essure+NovaSure

Description:

The group of women relying on Essure micro-inserts for permanent birth control when NovaSure is performed following a successful Essure Confirmation Test

Treatment:

Procedure: NovaSure

Device: ESS305 (Essure, BAY1454032)