Post Approval NovaSure Essure Labeling Study

UnknownOBSERVATIONAL
Enrollment

318

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

October 31, 2018

Study Completion Date

January 31, 2019

Conditions
Menorrhagia
Interventions
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.

Trial Locations (14)

27103

Lyndhurst Clinical Research, Winston-Salem

34239

Physicians Care Clinical Research, LLC, Sarasota

37203

Tennessee Women's Care, Nashville

37404

Chattanooga Medical Research, LLC, Chattanooga

45069

Amy Brenner MD & Associates, LLC, West Chester

45238

Seven Hills Women's Center, Cincinnati

48124

Oakwood Hospital and Medical Center, Dearborn

48604

Saginaw Valley Medical Research Group, LLC, Saginaw

55435

Minnesota Gynecology and Surgery, Edina

60515

Western DuPage Obstetrics and Gynecology, Downers Grove

80005

Westside Women's Care, Arvada

85224

New Horizon Women's Care, Chandler

87109

Bosque Women's Care, Albuquerque

99204

Rockwood Clinic, P.S., Spokane

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Hologic, Inc.

INDUSTRY

NCT01934244 - Post Approval NovaSure Essure Labeling Study | Biotech Hunter | Biotech Hunter