Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices (CAPTURE)

Astora Women's Health

Status: Terminated

Conditions: Female Stress Incontinence; Pelvic Organ Prolapse

Treatments: Device: RetroArc; Device: Mini Arc Pro; Device: Elevate PC

Study type: Observational

Funder types: Industry

Identifiers

NCT01673360

PR1102

Details and patient eligibility

About

To monitor post-market performance through evaluation of short and long-term performance via:

• Efficacy
• Safety
• Patient reported outcomes

Full 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

Enrollment: 401 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

401 participants in 3 patient groups

Elevate PC

Description:

Subjects implanted with Elevate PC

Treatment:

Device: Elevate PC

Mini Arc Pro

Description:

Subjects implanted with Mini Arc Pro

Treatment:

Device: Mini Arc Pro

RetroArc

Description:

Subjects implanted with RetroArc

Treatment:

Device: RetroArc