Trial record 3 of 11 for:    Open Studies | "Sterilization, Reproductive"

Essure-NovaSure Post Approval Study (ESS-NSPAS)

This study is currently recruiting participants.
Verified April 2014 by Bayer
Information provided by (Responsible Party):
Bayer Identifier:
First received: November 27, 2012
Last updated: April 7, 2014
Last verified: April 2014

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.

Condition Intervention
Device: Essure - Nova Sure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Approval Study Protocol: A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 1-Year Pregnancy Rate [ Time Frame: 1 year after NovaSure procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of Adverse Events [ Time Frame: After 3-year follow-up ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • 3-Year pregnancy rate [ Time Frame: 3-years after NovaSure procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: November 2012
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
The group of women receiving endometrial ablation using NovaSure after successful sterilization with the Essure device.
Device: Essure - Nova Sure
Other Names:
  • Essure Permanent Birth Control
  • Nova Sure Endometrial Ablation

Detailed Description:

This study has previously been posted by Conceptus, Inc. (US).

After acquiring Conceptus, Inc., Bayer HealthCare AG (Germany) is the sponsor of the trial.


Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects who have been identified as candidates for NovaSure Endometrial Ablation and have been/will be relying on Essure micro-inserts for permanent contraception (following a successful Essure Confirmation Test).


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.
  • Additional Inclusion Criteria

    • 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 who are willing and able to give written Informed Consent prior to participation in the post-approval study, in accordance with regulatory requirements
    • Women who are willing and able to complete all follow-up visits as required by the post-approval study protocol
    • Women who are willing and able to allow their data to be shared with the post -approval study Sponsor and the FDA

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.
  • Additional Exclusion Criteria

    • 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 who are scheduled to undergo any other intrauterine procedures at the time of Essure placement and/or subsequent NovaSure EA
  Contacts and Locations
Please refer to this study by its identifier: NCT01740687

Contact: Bayer Clinical Trials Contact
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

United States, Arizona
Not yet recruiting
Phoenix, Arizona, United States, 85015
United States, Colorado
Not yet recruiting
Denver, Colorado, United States, 80220
United States, Illinois
Not yet recruiting
Decatur, Illinois, United States, 62526
United States, Indiana
Not yet recruiting
Fort Wayne, Indiana, United States, 46825
Newburgh, Indiana, United States, 47630
United States, Maryland
Not yet recruiting
Easton, Maryland, United States, 21601
United States, Michigan
Not yet recruiting
Grand Blanc, Michigan, United States, 48439
United States, North Carolina
Not yet recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Not yet recruiting
Columbus, Ohio, United States, 43214
United States, Pennsylvania
Not yet recruiting
Pottstown, Pennsylvania, United States, 19464
United States, Tennessee
Not yet recruiting
Nashville, Tennessee, United States, 37205
United States, Washington
Not yet recruiting
Spokane, Washington, United States, 99202-1334
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer Identifier: NCT01740687     History of Changes
Other Study ID Numbers: 16975, ESS-NSPAS
Study First Received: November 27, 2012
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Endometrial Ablation
Permanent Sterilization
Prevention of Pregnancy

Additional relevant MeSH terms:
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes processed this record on April 17, 2014