A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test
ESS-NSPAS
1 other identifier
observational
211
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2012
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 13, 2012
CompletedFirst Submitted
Initial submission to the registry
November 27, 2012
CompletedFirst Posted
Study publicly available on registry
December 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2021
CompletedResults Posted
Study results publicly available
February 6, 2023
CompletedFebruary 6, 2023
February 1, 2023
8.5 years
November 27, 2012
May 6, 2022
February 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Pregnancies at 1-year Time Point (1-year Pregnancy Rate)
1 year after NovaSure Endometrial Ablation procedure
Number of Pregnancies at 3-year Time Point (3-year Pregnancy Rate)
3 years after NovaSure Endometrial Ablation procedure
Secondary Outcomes (1)
Number of Adverse Events (AEs) When NovaSure Endometrial Ablation Was Performed in the Presence of Essure Inserts
After 3-year follow-up
Study Arms (1)
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
Interventions
Eligibility Criteria
Clinics and hospitals
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (17)
Unknown Facility
Aurora, Colorado, 80045, United States
Unknown Facility
Ocala, Florida, 34471, United States
Unknown Facility
Decatur, Illinois, 62526, United States
Unknown Facility
Fort Wayne, Indiana, 46825, United States
Unknown Facility
Newburgh, Indiana, 47630, United States
Unknown Facility
Easton, Maryland, 21601, United States
Unknown Facility
Grand Blanc, Michigan, 48439, United States
Unknown Facility
Maplewood, Minnesota, 55109, United States
Unknown Facility
Las Vegas, Nevada, 89102, United States
Unknown Facility
Neptune City, New Jersey, 07753, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Englewood, Ohio, 45322, United States
Unknown Facility
Mason, Ohio, 45040, United States
Unknown Facility
Pottstown, Pennsylvania, 19464, United States
Unknown Facility
Nashville, Tennessee, 37232, United States
Unknown Facility
Norfolk, Virginia, 23507, United States
Unknown Facility
Spokane, Washington, 99204, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2012
First Posted
December 4, 2012
Study Start
November 13, 2012
Primary Completion
May 17, 2021
Study Completion
June 14, 2021
Last Updated
February 6, 2023
Results First Posted
February 6, 2023
Record last verified: 2023-02