Post Approval NovaSure Essure Labeling Study

Menorrhagia Clinical Trial

— PANEL  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01934244
• Other study ID #: S0112003
• Status: Enrolling by invitation
• Start date: December 2013
• Est. completion date: January 2019

Study information

• Verified date: July 2018
• Source: Hologic, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 318
• Est. completion date: January 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

• 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.

Related Conditions & MeSH terms

• Menorrhagia

Intervention

Device:
• NovaSure Endometrial Ablation
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.

Locations

Country	Name	City	State
United States	Bosque Women's Care	Albuquerque	New Mexico
United States	Westside Women's Care	Arvada	Colorado
United States	New Horizon Women's Care	Chandler	Arizona
United States	Chattanooga Medical Research, LLC	Chattanooga	Tennessee
United States	Seven Hills Women's Center	Cincinnati	Ohio
United States	Oakwood Hospital and Medical Center	Dearborn	Michigan
United States	Western DuPage Obstetrics and Gynecology	Downers Grove	Illinois
United States	Minnesota Gynecology and Surgery	Edina	Minnesota
United States	Tennessee Women's Care	Nashville	Tennessee
United States	Saginaw Valley Medical Research Group, LLC	Saginaw	Michigan
United States	Physicians Care Clinical Research, LLC	Sarasota	Florida
United States	Rockwood Clinic, P.S.	Spokane	Washington
United States	Amy Brenner MD & Associates, LLC	West Chester	Ohio
United States	Lyndhurst Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Hologic, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

Basinski CM, et al: Safety and Effectiveness of Novasure Endometrial Ablation After Placement of Essure Micro-inserts. Journal of Gynecologic Surgery 28(2), 2012

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number and percentage of subjects with adverse events	Adverse events reported during and/or immediately post operative the NovaSure procedure.; Adverse events reported up to 1 month after the NovaSure procedure	NovaSure Procedure visit (Day 1) and 1 month post NovaSure procedure

External Links

•   Hologic, Inc. website