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Completed

NCT Number: NCT01740687

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

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.

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Key information

Conditions

Contraception Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menorrhagia Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

21 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Aurora, Colorado, United States

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About this study

This study has previously been posted by Conceptus, Inc. After acquiring Conceptus, Inc., Bayer is now the sponsor of the trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ESS305 (Essure, BAY1454032)

Device

Essure Permanent Birth Control

NovaSure

Procedure

Nova Sure Endometrial Ablation

Primary outcomes

  1. Number of Pregnancies at 1-year Time Point (1-year Pregnancy Rate)

    Time frame: 1 year after NovaSure Endometrial Ablation procedure

  2. Number of Pregnancies at 3-year Time Point (3-year Pregnancy Rate)

    Time frame: 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

    Time frame: After 3-year follow-up

    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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Acronym: ESS-NSPAS

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Dec 4, 2012
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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