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To evaluate the safety and successful placement rate of Essure Model ESS310 device and any factors that may influence the successful placement rate of this device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESS310 | Experimental | All subjects that sign the informed consent and meet the eligibility criteria will be scheduled for an implant procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESS310 (BAY1454032) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of successful bilateral placement of the ESS310 insert at first attempt in subjects who undergo attempted ESS310 placement | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Successful bilateral placement rate of the ESS310 insert at first attempt in all subjects who undergo hysteroscopy with the intent of having bilateral ESS310 placement | Day 1 | |
| Evaluation of investigator questionnaire regarding ESS310 design and usability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale | Arizona | 85304 | United States | |||
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Potential aspects of the ESS310 design and usability that may impact bilateral placement rate at first attempt
| Day 1 |
| Evaluation of investigator questionnaire regarding potential factors predictive of failure to achieve bilateral placement of the ESS310 insert at first attempt | Day 1 |
| Hysteroscopy time to perform the procedure | Day 1 |
| Number of participants with Adverse device effects (ADE) as a measure of safety and tolerability | 1 week |
| Number of participants with Adverse procedure-related events as a measure of safety and tolerability | Day 1, 1 week |
| Phoenix |
| Arizona |
| 85015 |
| United States |
| Colorado Springs | Colorado | 80923 | United States |
| Augusta | Georgia | 30909 | United States |
| Fort Wayne | Indiana | 46825 | United States |
| Newburgh | Indiana | 47630 | United States |
| Grand Blanc | Michigan | 48439 | United States |
| Saginaw | Michigan | 48604 | United States |
| Wayne State University Physicians Group | Southfield | Michigan | 48034 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Dayton | Ohio | 45409-2793 | United States |
| Tennessee Women's Care, PC | Nashville | Tennessee | 37205 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Fort Worth | Texas | 76104 | United States |
| Houston | Texas | 77074 | United States |