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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)

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ClinicalTrials.gov Identifier: NCT01740687
Recruitment Status : Active, not recruiting
First Posted : December 4, 2012
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment
Contraception Menorrhagia Device: ESS305 (Essure, BAY1454032) Procedure: NovaSure

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
Actual Enrollment : 210 participants
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
Actual Study Start Date : November 13, 2012
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : March 14, 2022

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 1-Year Pregnancy Rate [ Time Frame: 1 year after NovaSure Endometrial Ablation procedure ]
  2. 3-Year Pregnancy Rate [ Time Frame: 3 years after NovaSure Endometrial Ablation procedure ]

Secondary Outcome Measures :
  1. Incidence of Adverse Events when Novasure endometrial ablation is performed in the presence of Essure inserts [ Time Frame: After 3-year follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
clinics and hospitals
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740687


Locations
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Ocala, Florida, United States, 34471
United States, Illinois
Decatur, Illinois, United States, 62526
United States, Indiana
Fort Wayne, Indiana, United States, 46825
Newburgh, Indiana, United States, 47630
United States, Maryland
Easton, Maryland, United States, 21601
United States, Michigan
Grand Blanc, Michigan, United States, 48439
United States, Minnesota
Maplewood, Minnesota, United States, 55109
United States, Nevada
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Neptune, New Jersey, United States, 07753
United States, North Carolina
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Englewood, Ohio, United States, 45322
Mason, Ohio, United States, 45040
United States, Pennsylvania
Pottstown, Pennsylvania, United States, 19464
United States, Tennessee
Nashville, Tennessee, United States, 37232
United States, Virginia
Norfolk, Virginia, United States, 23507
United States, Washington
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01740687     History of Changes
Other Study ID Numbers: 16975
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

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