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Sponsor is winding down business operations
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To monitor post-market performance through evaluation of short and long-term performance via:
As this is a post-market registry on market approved devices, there will be no formal hypothesis testing. However, points of evaluation will include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elevate PC | Subjects implanted with Elevate PC |
| |
| Mini Arc Pro | Subjects implanted with Mini Arc Pro |
| |
| RetroArc | Subjects implanted with RetroArc |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elevate PC | Device | List of AMS prolapse products |
| |
| Mini Arc Pro |
| Measure | Description | Time Frame |
|---|---|---|
| Prolapse Efficacy - POP-Q | Prolapse Endpoints: • POP-Q measurement | annually, upto 5 years |
| Urinary Incontinence Endpoints | Urinary Incontinence Endpoints:
| annually upto 5 years |
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Inclusion Criteria:
Patients must meet all of the following criteria to be considered for inclusion in the registry.
Exclusion Criteria:
Patients will be excluded from the registry if any one of the following criteria is met.
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All patients planned to receive at least one (1) target AMS market approved female pelvic health product will be considered for inclusion in the registry.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta Medical Research Institute | Alpharetta | Georgia | 30005 | United States | ||
| Morristown Memorial Hospital |
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| Device |
List of AMS Urinary Incontinence devices |
|
| RetroArc | Device | List of AMS Urinary Incontinence devices |
|
| Morristown |
| New Jersey |
| 07962 |
| United States |
| Womancare | Winston-Salem | North Carolina | 27103 | United States |
| Seven Hills Women's Health Centers | Cinncinatti | Ohio | 45242 | United States |
| The Female Pelvic Health Center | Newtown | Pennsylvania | 18940 | United States |
| Female Pelvic Medicine Institute of Virginia | Richmond | Virginia | 23235 | United States |
| The Ottawa Hospital - Shirley E. Greenberg Women's Health Centre | Ottawa | Ontario | K1H 7W9 | Canada |
| Windsor Research Office | Windsor | Ontario | N8W 5L7 | Canada |
| CMC Beau Soleil | Montpellier | 34070 | France |
| Hôpital BICÊTRE | Paris | France |
| German Pelvic Floor Center, St. Hedwig Hospital | Berlin | 11 10115 | Germany |
| Waldburg-Zeil Kliniken Klinik Tettnang | Tettnang | 16 88069 | Germany |
| University Medical Centre Maribor | Maribor | Slovenia |
| Pretoria Urology Hospital | Pretoria | South Africa |
| Hospital Clínico y Provincial de Barcelona | Barcelona | Spain |
| Hospital Beata María Ana de Jesus | Madrid | Spain |
| Hospital Rio Hortega | Valladolid | Spain |
| Royal Bolton Hospital | Bolton | United Kingdom |
| Glasgow - Southern General Hospital | Glasgow | United Kingdom |
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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