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.

Conditions

Eligibility

Eligible Ages
Between 21 Years and 50 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Essure+NovaSure The group of women relying on Essure micro-inserts for permanent birth control when NovaSure is performed following a successful Essure Confirmation Test
  • Device: ESS305 (Essure, BAY1454032)
    Essure Permanent Birth Control
  • Procedure: NovaSure
    Nova Sure Endometrial Ablation

Recruiting Locations

Nashville, Tennessee 37232

More Details

NCT ID
NCT01740687
Status
Recruiting
Sponsor
Bayer

Study Contact

Bayer Clinical Trials Contact
(+)1-888-84 22937
clinical-trials-contact@bayer.com

Detailed Description

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.