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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Per Protocol | All enrolled patients in which all inclusion/exclusion criteria were met and the NovaSure endometrial ablation was completed. |
| |
| Primary | All enrolled patients in whom the Novasure device was inserted. | ||
| Intent to treat | All enrolled patients in which NovaSure device was attempted. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Edward Evantash, MD | Hologic, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Horizon Women's Care | Chandler | Arizona | 85224 | United States | ||
| Westside Women's Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24761128 | Background | 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. | |
| Background | Saunders, D: Essure and Endometrial Ablation: Clinical studies and case reviews of Essure with 118 NovaSure procedures, Supplement to OBG Management, April, 2010. |
| Label | URL |
|---|---|
| Hologic, Inc. website | View source |
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| ID | Term |
|---|---|
| D008595 | Menorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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|
| Arvada |
| Colorado |
| 80005 |
| United States |
| Physicians Care Clinical Research, LLC | Sarasota | Florida | 34239 | United States |
| Western DuPage Obstetrics and Gynecology | Downers Grove | Illinois | 60515 | United States |
| Oakwood Hospital and Medical Center | Dearborn | Michigan | 48124 | United States |
| Saginaw Valley Medical Research Group, LLC | Saginaw | Michigan | 48604 | United States |
| Minnesota Gynecology and Surgery | Edina | Minnesota | 55435 | United States |
| Bosque Women's Care | Albuquerque | New Mexico | 87109 | United States |
| Lyndhurst Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Seven Hills Women's Center | Cincinnati | Ohio | 45238 | United States |
| Amy Brenner MD & Associates, LLC | West Chester | Ohio | 45069 | United States |
| Chattanooga Medical Research, LLC | Chattanooga | Tennessee | 37404 | United States |
| Tennessee Women's Care | Nashville | Tennessee | 37203 | United States |
| Rockwood Clinic, P.S. | Spokane | Washington | 99204 | United States |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |