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

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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)

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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