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NCT00626821 · ClinicalTrials.gov registry record · Phase 4

Coloplast DialogueStudy

A Phase 4 study, sponsored by Coloplast A/S.

Completed
Registry status
Phase 4
Development phase
3,017
Enrollment target

NCT00626821: Completed Phase 4 study, sponsored by Coloplast A/S.

NCT00626821 is a Phase 4 study that has completed, run by Coloplast A/S. The registered enrollment target is 3,017 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (482% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00626821, a Phase 4 study, has completed, sponsored by Coloplast A/S.

COMPLETED
Registry status
Phase 4
Development phase
3,017 participants
Enrollment target

Study Summary

The main purpose of the study is to document real life experience on SenSura with focus on skin condition and quality of life.

Primary Outcome

The mean change in quality of life (Stoma-QoL value) from visit 1 to visit 2. An increase in Stoma-QoL is an improvement, a decrease in Stoma-QoL is a worsening.

Interventions

  • DEVICE SenSura

Trial Details

FieldValue
Enrollment Target 3,017 participants
Start Date 2008-02
Est. Completion 2010-12
Phase Phase 4
Coloplast A/S

21 total trials

What the finished NCT00626821 record still lists

NCT00626821 is an interventional study that assigns participants to a tested intervention. Its 3,017 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (482% higher).

The record links to 0 conditions, and to 1 intervention - of which SenSura is the first listed.

NCT00626821 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00626821 about?

NCT00626821 is a clinical study titled "Coloplast DialogueStudy". The main purpose of the study is to document real life experience on SenSura with focus on skin condition and quality of life.

What is the current status of trial NCT00626821?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 3,017 participants. The study started on 2008-02. Estimated completion is 2010-12.

What interventions are being tested in trial NCT00626821?

The interventions under investigation include: SenSura (DEVICE).

Who is sponsoring clinical trial NCT00626821?

This trial is sponsored by Coloplast A/S, which has 21 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00626821's enrollment target sits among peer trials

3,017 25th of 2000 higher than 1,976 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT00626821, the US trial registry maintained by the National Library of Medicine. NCT00626821 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.