CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
CP321device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04894084
NCT04894084N/ACompleted
CompareCT.gov

Investigation of a Supporting Ostomy Product Intended for Leakage Detection

Coloplast A/S·interventional·Posted May 20, 2021·Updated Sep 22, 2023

In Brief

A clinical study evaluating CP321 for Stoma Ileostomy. Completed, enrolled 25 participants across 1 site.

Detailed Summary

People with intestinal stomas (especially an ileostomy) can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively. To overcome this, Coloplast has developed a new supporting ostomy product, which has an adhesive sensor layer that should be place underneath the baseplate normally used by the subject. Single arm design. Open-labelled Study duration: 21 days + 3 days.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStoma Ileostomy
CountriesDenmark
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMay 20, 2021
Enrollment StartApr 29, 2021
Primary CompletionJul 14, 2021
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.1 years ago

Interventions

CP321device

The primary objective is to evaluate the system performance of the test product. This is done by asking subjects to answer questions throughout the study