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Post Approval NovaSure Essure Labeling Study

Evaluation of the Safety of NovaSure in the Presence of Essure Following the Essure Confirmation Test (ECT) Post-Approval Study

NCT01934244•Hologic, Inc.

View on ClinicalTrials.gov

Summary

This post approval, observational study is being conducted to further evaluate the safety of the NovaSure Endometrial Ablation System when it is performed in the presence of Essure micro-inserts.

Detailed Description

A prospective, single arm, multi-center, post approval study that is designed to provide additional information on the safety of performing a NovaSure Impedence Controlled Endometrial Ablation System in the presence of Essure Permanent Birth Control System, following the Essure Confirmation Test has confirmed both bilateral tubal occlusion and the satisfactory location of the Essure micro-inserts. The study will be conducted at up to 15 clinical sites and enroll 318 patients. Patients who meet the inclusion and none of the exclusion criteria will have the study explained to them and be invited to participate. Enrolled subjects will have baseline data collected at the time of their NovaSure procedure and will be followed for 1 month after the NovaSure procedure to be assessed for adverse events.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Subject is 18 years of age or older and premenopausal.
•Subject's gynecological history supports the use of NovaSure endometrial ablation for the treatment of menorrhagia.
•Subject has had an Essure Permanent Birth Control System procedure.
•The Essure Confirmation Test has confirmed both bilateral tubal occlusion and satisfactory placement of the Essure micro-inserts. A written report or ECT radiologic films need to be provided by the physician who performed the ECT. If neither is available, the ECT must be repeated prior to enrollment.
•Subject is able to provide informed consent

Exclusion Criteria

•Subject has known or suspected endometrial carcinoma (uterine cancer) or pre-malignant conditions of the endometrium, such as unresolved (atypical) adenomatous hyperplasia.
•Subject has abnormal/obstructive uterine cavity as confirmed by hysteroscopy or other imaging study (e.g. congenital malformation, large fibroid or large polyp)
•Subject with any anatomic condition (e.g. history of previous classical cesarean section or transmural myomectomy) or pathologic condition (e.g. long term medical therapy) that could lead to weakening of the myometrium.
•Subject has an active genital or urinary tract infection at the time of the procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis, or cystitis).
•Subject has an intrauterine device (IUD) currently in place.
•Subject has active pelvic inflammatory disease or history of recent pelvic infection.
•Subject has undiagnosed vaginal bleeding.
•ECT unable to adequately assess bilateral tubal occlusion and proper micro-insert placement.
•Subject has uterine sound measurement greater than 10 cm.
•Subject with a uterine cavity length less than 4 cm.
+3 more criteria

Locations (14)

New Horizon Women's Care

Chandler, Arizona, United States

Westside Women's Care

Arvada, Colorado, United States

Physicians Care Clinical Research, LLC

Sarasota, Florida, United States

Western DuPage Obstetrics and Gynecology

Downers Grove, Illinois, United States

Oakwood Hospital and Medical Center

Dearborn, Michigan, United States

Saginaw Valley Medical Research Group, LLC

Saginaw, Michigan, United States

Minnesota Gynecology and Surgery

Edina, Minnesota, United States

Bosque Women's Care

Albuquerque, New Mexico, United States

Lyndhurst Clinical Research

Winston-Salem, North Carolina, United States

Seven Hills Women's Center

Cincinnati, Ohio, United States

Key Dates

Start Date

December 1, 2013

Primary Completion Date

October 1, 2018

Completion Date

January 1, 2019

Last Updated

July 30, 2018

Enrollment

318

ESTIMATED participants

Conditions

Menorrhagia

Interventions

NovaSure Endometrial Ablation

DEVICE

Effects of Resistance Training Intensity on Cardiovascular Parameters of Hypertensive Women

NCT06538454

Arterial HypertensionPostmenopausal; Menorrhagia+1 more

View study

COMPLETEDNA

Efficiency of Lina LibrataTM System

NCT03670680

Menorrhagia

View study

WITHDRAWN

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 30, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Post Approval NovaSure Essure Labeling Study

Inclusion Criteria

Exclusion Criteria

Effects of Resistance Training Intensity on Cardiovascular Parameters of Hypertensive Women

Efficiency of Lina LibrataTM System

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