CAPTURE: Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices
Study Details
Study Description
Brief Summary
To monitor post-market performance through evaluation of short and long-term performance via:
-
Efficacy
-
Safety
-
Patient reported outcomes
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Detailed Description
As this is a post-market registry on market approved devices, there will be no formal hypothesis testing. However, points of evaluation will include:
-
Characterize the efficacy of the AMS market approved female pelvic health products using standard of care outcome measures and validated quality of life questionnaires
-
Characterize the type, severity, and rate of adverse events related to each AMS market approved female pelvic health product
-
Collect concomitant procedural data related to the pelvic floor area
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Elevate PC Subjects implanted with Elevate PC |
Device: Elevate PC
List of AMS prolapse products
|
Mini Arc Pro Subjects implanted with Mini Arc Pro |
Device: Mini Arc Pro
List of AMS Urinary Incontinence devices
|
RetroArc Subjects implanted with RetroArc |
Device: RetroArc
List of AMS Urinary Incontinence devices
|
Outcome Measures
Primary Outcome Measures
- Prolapse Efficacy - POP-Q [annually, upto 5 years]
Prolapse Endpoints: • POP-Q measurement
- Urinary Incontinence Endpoints [annually upto 5 years]
Urinary Incontinence Endpoints: Cough stress test 1 hour pad weight test Urodynamics
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients must meet all of the following criteria to be considered for inclusion in the registry.
-
Have a signed Informed Consent Form
-
Have a signed HIPAA Authorization Form or equivalent Patient Privacy Form if required outside of the US
-
Is a female at least 18 years of age
-
Is scheduled to receive at least one (1) AMS market approved female pelvic health implantable product.
-
Is able and willing to participate in the registry
Exclusion Criteria:
-
Patients will be excluded from the registry if any one of the following criteria is met.
-
Patients are contraindicated to receive the target AMS market approved female pelvic health product per the product's IFU
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Atlanta Medical Research Institute | Alpharetta | Georgia | United States | 30005 |
2 | Morristown Memorial Hospital | Morristown | New Jersey | United States | 07962 |
3 | Womancare | Winston-Salem | North Carolina | United States | 27103 |
4 | Seven Hills Women's Health Centers | Cinncinatti | Ohio | United States | 45242 |
5 | The Female Pelvic Health Center | Newtown | Pennsylvania | United States | 18940 |
6 | Female Pelvic Medicine Institute of Virginia | Richmond | Virginia | United States | 23235 |
7 | The Ottawa Hospital - Shirley E. Greenberg Women's Health Centre | Ottawa | Ontario | Canada | K1H 7W9 |
8 | Windsor Research Office | Windsor | Ontario | Canada | N8W 5L7 |
9 | CMC Beau Soleil | Montpellier | France | 34070 | |
10 | Hôpital BICÊTRE | Paris | France | ||
11 | German Pelvic Floor Center, St. Hedwig Hospital | Berlin | Germany | 11 10115 | |
12 | Waldburg-Zeil Kliniken Klinik Tettnang | Tettnang | Germany | 16 88069 | |
13 | University Medical Centre Maribor | Maribor | Slovenia | ||
14 | Pretoria Urology Hospital | Pretoria | South Africa | ||
15 | Hospital Clínico y Provincial de Barcelona | Barcelona | Spain | ||
16 | Hospital Beata María Ana de Jesus | Madrid | Spain | ||
17 | Hospital Rio Hortega | Valladolid | Spain | ||
18 | Royal Bolton Hospital | Bolton | United Kingdom | ||
19 | Glasgow - Southern General Hospital | Glasgow | United Kingdom |
Sponsors and Collaborators
- ASTORA Women's Health
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PR1102