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NCT01138709 · ClinicalTrials.gov registry record · NA
Vitala 12 Hour Wear Test With Convex Products
A NA study, sponsored by ConvaTec.
- Completed
- Registry status
- NA
- Development phase
- 27
- Enrollment target
NCT01138709: Completed NA study, sponsored by ConvaTec.
NCT01138709 is a NA study that has completed, run by ConvaTec. The registered enrollment target is 27 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01138709, a NA study, has completed, sponsored by ConvaTec.
- COMPLETED
- Registry status
- NA
- Development phase
- 27 participants
- Enrollment target
Study Summary
The primary objective of this phase II clinical trial is to assess the safety of the Vitala™ device during 12 hours of daily wear with convex products.
Primary Outcome
Assess safety during 12 hours of Vitala™ device wear with convex products by measuring the frequency of adverse events relating to the stoma (including gastrointestinal, stomal and surrounding skin events), and stomal vascularity.
Interventions
- DEVICE Vitala
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2010-02 |
| Est. Completion | 2010-04 |
| Phase | NA |
What the finished NCT01138709 record still lists
NCT01138709 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Vitala is the first listed.
NCT01138709 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01138709 about?
NCT01138709 is a clinical study titled "Vitala 12 Hour Wear Test With Convex Products". The primary objective of this phase II clinical trial is to assess the safety of the Vitala™ device during 12 hours of daily wear with convex products.
What is the current status of trial NCT01138709?
This trial is currently completed. It is a NA study. The enrollment target is 27 participants. The study started on 2010-02. Estimated completion is 2010-04.
What interventions are being tested in trial NCT01138709?
The interventions under investigation include: Vitala (DEVICE).
Who is sponsoring clinical trial NCT01138709?
This trial is sponsored by ConvaTec, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01138709's enrollment target sits among peer trials
27 1708th of 2000 higher than 291 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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