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NCT02348112 · ClinicalTrials.gov registry record
Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence
A clinical trial, sponsored by Coloplast A/S.
- Completed
- Registry status
- 416
- Enrollment target
NCT02348112: Completed study, sponsored by Coloplast A/S.
NCT02348112 is a clinical trial that has completed, run by Coloplast A/S. The registered enrollment target is 416 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02348112 has completed, sponsored by Coloplast A/S.
- COMPLETED
- Registry status
- 416 participants
- Enrollment target
Study Summary
The aim of this postmarket study is to compare the safety and effectiveness of the Altis Single Incision Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36 months.
Primary Outcome
Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50% at 6 months.
Interventions
- DEVICE Altis Single Incision Sling
- DEVICE Transobturator or Retropubic Sling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 416 participants |
| Start Date | 2015-01 |
| Est. Completion | 2021-09 |
What the finished NCT02348112 record still lists
NCT02348112 is an observational study that tracks outcomes without assigning an intervention. The registered 416 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Altis Single Incision Sling is the first listed.
NCT02348112 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02348112 about?
NCT02348112 is a clinical study titled "Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence". The aim of this postmarket study is to compare the safety and effectiveness of the Altis Single Incision Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36 months.
What is the current status of trial NCT02348112?
This trial is currently completed. The enrollment target is 416 participants. The study started on 2015-01. Estimated completion is 2021-09.
What interventions are being tested in trial NCT02348112?
The interventions under investigation include: Altis Single Incision Sling (DEVICE), Transobturator or Retropubic Sling (DEVICE).
Who is sponsoring clinical trial NCT02348112?
This trial is sponsored by Coloplast A/S, which has 21 total clinical trials registered on ClinicalTrials.gov.
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