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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01740687
Recruitment Status : Active, not recruiting
First Posted : December 4, 2012
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date November 27, 2012
First Posted Date December 4, 2012
Last Update Posted Date October 12, 2020
Actual Study Start Date November 13, 2012
Estimated Primary Completion Date July 3, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 9, 2014)
  • 1-Year Pregnancy Rate [ Time Frame: 1 year after NovaSure Endometrial Ablation procedure ]
  • 3-Year Pregnancy Rate [ Time Frame: 3 years after NovaSure Endometrial Ablation procedure ]
Original Primary Outcome Measures
 (submitted: November 30, 2012)
1-Year Pregnancy Rate [ Time Frame: 1 year after NovaSure procedure ]
Change History
Current Secondary Outcome Measures
 (submitted: February 5, 2015)
Incidence of Adverse Events when Novasure endometrial ablation is performed in the presence of Essure inserts [ Time Frame: After 3-year follow-up ]
Original Secondary Outcome Measures
 (submitted: November 30, 2012)
Incidence of Adverse Events [ Time Frame: After 3-year follow-up ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: November 30, 2012)
3-Year pregnancy rate [ Time Frame: 3-years after NovaSure procedure ]
 
Descriptive Information
Brief Title A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test
Official Title A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test
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.
Detailed Description This study has previously been posted by Conceptus, Inc. After acquiring Conceptus, Inc., Bayer is now the sponsor of the trial.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Clinics and hospitals
Condition
  • Contraception
  • Menorrhagia
Intervention
  • Device: ESS305 (Essure, BAY1454032)
    Essure Permanent Birth Control
  • Procedure: NovaSure
    Nova Sure Endometrial Ablation
Study Groups/Cohorts 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:
  • Device: ESS305 (Essure, BAY1454032)
  • Procedure: NovaSure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: September 24, 2019)
209
Original Enrollment Not Provided
Estimated Study Completion Date July 29, 2021
Estimated Primary Completion Date July 3, 2021   (Final data collection date for primary outcome measure)
Eligibility 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 and unwilling to have it removed before NovaSure
Sex/Gender
Sexes Eligible for Study: Female
Ages 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01740687
Other Study ID Numbers 16975
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Bayer
Study Sponsor Bayer
Collaborators Not Provided
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date October 2020