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

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.

Study Overview

• Status: Completed
• Conditions: Contraception; Menorrhagia
• Intervention / Treatment: 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
• Enrollment (Actual): 211

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Clinics and hospitals

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events (AEs) When NovaSure Endometrial Ablation Was Performed in the Presence of Essure Inserts	An adverse event (AE) is any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom, or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. A serious adverse event (SAE) is classified as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is another serious or important medical event (IME) as judged by the investigator, or requires intervention to prevent permanent impairment of a body function or damage to a body structure.	After 3-year follow-up

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer Healthcare products.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 13, 2012
• Primary Completion (ACTUAL): May 17, 2021
• Study Completion (ACTUAL): June 14, 2021

Study Registration Dates

• First Submitted: November 27, 2012
• First Submitted That Met QC Criteria: November 30, 2012
• First Posted (ESTIMATE): December 4, 2012

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Endometrial Ablation; NovaSure; Essure; Permanent Sterilization; Prevention of Pregnancy
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Menstruation Disturbances; Uterine Hemorrhage; Menorrhagia
• Other Study ID Numbers: 16975

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No