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The trial objectives include evaluating the adequacy of proposed mitigations for the previous pivotal trial of the FemBloc Permanent Contraceptive System and validating the confirmation procedure by comparing FemChec (ultrasound) to fluoroscopic hysterosalpingogram (fluoro HSG) for post-occlusion in the same patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FemBloc | Experimental | Investigational device and procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FemBloc | Device | Treatment with FemBloc for women who desire permanent birth control (female sterilization) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reliance Rate | Number of subjects told to rely divided by number of qualified subjects | within 1 year |
| Concordance | Concordance between FemBloc confirmation with FemChec and Fluoro HSG confirmation | within 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Horizons Clinical Trials | Chandler | Arizona | 85224 | United States | ||
| Precision Trials AZ, LLC |
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| Phoenix |
| Arizona |
| 85032 |
| United States |
| Midtown OB GYN North | Columbus | Georgia | 31909 | United States |
| Women's Health Advantage | Fort Wayne | Indiana | 46825 | United States |
| Saginaw Valley Medical Research Group | Saginaw | Michigan | 48604 | United States |
| University Hospitals - Cleveland Medical Center | Beachwood | Ohio | 44122 | United States |