Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices
Status: | Terminated |
---|---|
Conditions: | Women's Studies, Women's Studies, Urology |
Therapuetic Areas: | Nephrology / Urology, Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/18/2016 |
Start Date: | September 2012 |
End Date: | December 2021 |
To monitor post-market performance through evaluation of short and long-term performance
via:
- Efficacy
- Safety
- Patient reported outcomes
via:
- Efficacy
- Safety
- Patient reported outcomes
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
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
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
We found this trial at
7
sites
Morristown Memorial Hospital Atlantic Health System – comprised of Morristown Medical Center, Overlook Medical Center,...
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