Clinical trial NCT01740687: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Menorrhagia
Keywords: Endometrial Ablation
Permanent Sterilization
Essure
NovaSure
Prevention of Pregnancy
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-12-04
Enrollment: 211
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinics and hospitals

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.

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

Primary outcomes:
measure: Number of Pregnancies at 1-year Time Point (1-year Pregnancy Rate)
timeFrame: 1 year after NovaSure Endometrial Ablation procedure
measure: Number of Pregnancies at 3-year Time Point (3-year Pregnancy Rate)
timeFrame: 3 years after NovaSure Endometrial Ablation procedure
Secondary outcomes:
measure: Number of Adverse Events (AEs) When NovaSure Endometrial Ablation Was Performed in the Presence of Essure Inserts
timeFrame: After 3-year follow-up
Other outcomes:
Locations:
city: Aurora
country: United States
state: Colorado
city: Ocala
country: United States
state: Florida
city: Decatur
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: Newburgh
country: United States
state: Indiana
city: Easton
country: United States
state: Maryland
city: Grand Blanc
country: United States
state: Michigan
city: Maplewood
country: United States
state: Minnesota
city: Las Vegas
country: United States
state: Nevada
city: Neptune
country: United States
state: New Jersey
city: Winston-Salem
country: United States
state: North Carolina
city: Englewood
country: United States
state: Ohio
city: Mason
country: United States
state: Ohio
city: Pottstown
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Norfolk
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: