Essure-NovaSure Post Approval Study (ESS-NSPAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01740687
First received: November 27, 2012
Last updated: August 4, 2014
Last verified: August 2014
  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.


Condition Intervention
Contraception
Menorrhagia
Device: ESS305 (Essure, BAY1454032)
Procedure: NovaSure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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 Endometrial Ablation procedure ] [ Designated as safety issue: No ]
  • 3-Year Pregnancy Rate [ Time Frame: 3 years after NovaSure Endometrial Ablation procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with adverse events as a measure of safety [ Time Frame: Up to 3 years ] [ 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
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01740687

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

Locations
United States, Arizona
Recruiting
Phoenix, Arizona, United States, 85015
United States, Colorado
Terminated
Denver, Colorado, United States, 80220
United States, Illinois
Recruiting
Decatur, Illinois, United States, 62526
United States, Indiana
Recruiting
Fort Wayne, Indiana, United States, 46825
Recruiting
Newburgh, Indiana, United States, 47630
United States, Maryland
Recruiting
Easton, Maryland, United States, 21601
United States, Michigan
Recruiting
Grand Blanc, Michigan, United States, 48439
United States, North Carolina
Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Terminated
Columbus, Ohio, United States, 43214
United States, Pennsylvania
Recruiting
Pottstown, Pennsylvania, United States, 19464
United States, Tennessee
Recruiting
Nashville, Tennessee, United States, 37205
United States, Washington
Recruiting
Spokane, Washington, United States, 99202-1334
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01740687     History of Changes
Other Study ID Numbers: 16975, ESS-NSPAS
Study First Received: November 27, 2012
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes

ClinicalTrials.gov processed this record on August 27, 2014