Post Approval NovaSure Essure Labeling Study

NCT01934244 | Unknown

• 1 other identifier: S0112003
• Study Type: observational
• Target: 318
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Menorrhagia

Outcome Measures

Primary Outcomes (1)

• Rate of Essure micro-insert removal with NovaSure device

  At the end of the NovaSure treatment and upon removal of the NovaSure device, the device will be directly observed to see if any Essure micro-insert(s) is(are) attached.

  NovaSure procedure visit (Day 1)

Secondary Outcomes (1)

• Number and percentage of subjects with adverse events

  NovaSure Procedure visit (Day 1) and 1 month post NovaSure procedure

Study Arms (3)

Per Protocol

All enrolled patients in which all inclusion/exclusion criteria were met and the NovaSure endometrial ablation was completed.

Device: NovaSure Endometrial Ablation

Primary

All enrolled patients in whom the Novasure device was inserted.

Intent to treat

All enrolled patients in which NovaSure device was attempted.

Interventions

NovaSure Endometrial Ablation DEVICE

The NovaSure Endometrial Ablation device consists of a disposable single-use, conformable bipolar electrode array mounted on an expandable frame that can create a confluent lesion on the entire interior surface area of the uterine cavity. The device is inserted transcervically into the uterine cavity, and the sheath is retracted to allow the bipolar electrode array to be deployed and conform to the uterine cavity. The disposable device works in conjunction with a dedicated NovaSure RF (radio frequency) controller to perform customized, global endometrial ablation.

Per Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Premenopausal women 18 years of age or older who have abnormal uterine bleeding and are candidates for a NovaSure Endometrial Ablation that have already had an Essure Permanent Birth Control system procedure and an Essure Confirmation Test that has confirmed both bilateral tubal occlusion and the satisfactory location of the Essure micro-inserts.

You may qualify if:

• 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

You may not qualify if:

• 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.
• Subject with a uterine cavity width less than 2.5 cm, as determined by the width dial of the disposable NovaSure device following device deployment.
• Subject is unable to comply with the protocol and be available for follow up
• In the opinion of the investigator, the subject has a medical condition that precludes safe participation in the study.

Sponsors & Collaborators

• Hologic, Inc.: lead

Study Sites (14)

New Horizon Women's Care

Chandler, Arizona, 85224, United States

Location

Westside Women's Care

Arvada, Colorado, 80005, United States

Location

Physicians Care Clinical Research, LLC

Sarasota, Florida, 34239, United States

Location

Western DuPage Obstetrics and Gynecology

Downers Grove, Illinois, 60515, United States

Location

Oakwood Hospital and Medical Center

Dearborn, Michigan, 48124, United States

Location

Saginaw Valley Medical Research Group, LLC

Saginaw, Michigan, 48604, United States

Location

Minnesota Gynecology and Surgery

Edina, Minnesota, 55435, United States

Location

Bosque Women's Care

Albuquerque, New Mexico, 87109, United States

Location

Lyndhurst Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Seven Hills Women's Center

Cincinnati, Ohio, 45238, United States

Location

Amy Brenner MD & Associates, LLC

West Chester, Ohio, 45069, United States

Location

Chattanooga Medical Research, LLC

Chattanooga, Tennessee, 37404, United States

Location

Tennessee Women's Care

Nashville, Tennessee, 37203, United States

Location

Rockwood Clinic, P.S.

Spokane, Washington, 99204, United States

Location

Related Publications (2)

• Basinski CM, Price P, Burkhart J, Johnson J. Safety and Effectiveness of NovaSure(R) Endometrial Ablation After Placement of Essure(R) Micro-Inserts. J Gynecol Surg. 2012 Apr;28(2):83-88. doi: 10.1089/gyn.2011.0061.

  PMID: 24761128 BACKGROUND

• Saunders, D: Essure and Endometrial Ablation: Clinical studies and case reviews of Essure with 118 NovaSure procedures, Supplement to OBG Management, April, 2010.

  BACKGROUND

Related Links

• Hologic, Inc. website

MeSH Terms

Conditions

Menorrhagia

Condition Hierarchy (Ancestors)

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

Study Officials

• Edward Evantash, MD

  Hologic, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2013
• First Posted: September 4, 2013
• Study Start: December 1, 2013
• Primary Completion: October 1, 2018
• Study Completion: January 1, 2019
• Last Updated: July 30, 2018

Record last verified: 2018-07

Locations

US (14)