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NCT01272284 · ClinicalTrials.gov registry record · NA
The Altis® Single Incision Sling System for Female Stress Urinary Incontinence Study
A NA study, sponsored by Coloplast A/S.
- Completed
- Registry status
- NA
- Development phase
- 113
- Enrollment target
NCT01272284: Completed NA study, sponsored by Coloplast A/S.
NCT01272284 is a NA study that has completed, run by Coloplast A/S. The registered enrollment target is 113 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01272284, a NA study, has completed, sponsored by Coloplast A/S.
- COMPLETED
- Registry status
- NA
- Development phase
- 113 participants
- Enrollment target
Study Summary
An international, multi-center, single arm, prospective clinical study designed to assess the safety and efficacy of the Coloplast Altis single incision sling system for females with stress urinary incontinence (SUI).
Primary Outcome
Primary endpoint defined as at least a 50% reduction in 24-hour pad weight from baseline to 6 months (including dry as defined as a pad weight of less than 1.3 grams during the 6-month test), in which the percent of subjects with at least 50% reduction in 24-hour pad weight is compared to a performance goal of 50%.
Interventions
- DEVICE Altis® Single Incision Sling System (SIS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2010-12 |
| Est. Completion | 2014-01 |
| Phase | NA |
What the finished NCT01272284 record still lists
NCT01272284 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Altis® Single Incision Sling System (SIS) is the first listed.
NCT01272284 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01272284 about?
NCT01272284 is a clinical study titled "The Altis® Single Incision Sling System for Female Stress Urinary Incontinence Study". An international, multi-center, single arm, prospective clinical study designed to assess the safety and efficacy of the Coloplast Altis single incision sling system for females with stress urinary incontinence (SUI).
What is the current status of trial NCT01272284?
This trial is currently completed. It is a NA study. The enrollment target is 113 participants. The study started on 2010-12. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01272284?
The interventions under investigation include: Altis® Single Incision Sling System (SIS) (DEVICE).
Who is sponsoring clinical trial NCT01272284?
This trial is sponsored by Coloplast A/S, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01272284's enrollment target sits among peer trials
113 813th of 2000 higher than 1,188 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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