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NCT00902252 · ClinicalTrials.gov registry record · Phase 3

Multi-National Phase III Vitala™ 12-Hour Wear Test

A Phase 3 study, sponsored by ConvaTec.

Completed
Registry status
Phase 3
Development phase
78
Enrollment target

NCT00902252: Completed Phase 3 study, sponsored by ConvaTec.

NCT00902252 is a Phase 3 study that has completed, run by ConvaTec. The registered enrollment target is 78 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00902252, a Phase 3 study, has completed, sponsored by ConvaTec.

COMPLETED
Registry status
Phase 3
Development phase
78 participants
Enrollment target

Study Summary

The purpose of this clinical study is to demonstrate that the Vitala™ Continence Control Device is both safe and effective when worn up to 12 hours per day.

Primary Outcome

Will be assessed by measuring the frequency of adverse events relating to the stoma (including gastrointestinal, stomal and surrounding skin events), microbiology profile and stomal vascularity.

Interventions

  • DEVICE Usual
  • DEVICE Natura®
  • DEVICE Vitala™

Trial Details

FieldValue
Enrollment Target 78 participants
Start Date 2009-04
Est. Completion 2010-01
Phase Phase 3
ConvaTec

17 total trials

What the finished NCT00902252 record still lists

NCT00902252 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 3 interventions - of which Usual is the first listed.

NCT00902252 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00902252 about?

NCT00902252 is a clinical study titled "Multi-National Phase III Vitala™ 12-Hour Wear Test". The purpose of this clinical study is to demonstrate that the Vitala™ Continence Control Device is both safe and effective when worn up to 12 hours per day.

What is the current status of trial NCT00902252?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 78 participants. The study started on 2009-04. Estimated completion is 2010-01.

What interventions are being tested in trial NCT00902252?

The interventions under investigation include: Usual (DEVICE), Natura® (DEVICE), Vitala™ (DEVICE).

Who is sponsoring clinical trial NCT00902252?

This trial is sponsored by ConvaTec, which has 17 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00902252's enrollment target sits among peer trials

78 1769th of 2000 higher than 230 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT00902252, the US trial registry maintained by the National Library of Medicine. NCT00902252 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.