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.
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.
Study Type
OBSERVATIONAL
Enrollment
318
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.
New Horizon Women's Care
Chandler, Arizona, United States
Westside Women's Care
Arvada, Colorado, United States
Physicians Care Clinical Research, LLC
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.
Time frame: NovaSure procedure visit (Day 1)
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
Time frame: NovaSure Procedure visit (Day 1) and 1 month post NovaSure procedure
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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
...and 4 more locations