CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 38 enrolled
Drug / intervention
Coloplast Test +2 moredevice
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/NCT02043782
NCT02043782N/ACompleted

Investigation of a New 1-piece Convex Ostomy Product in Subjects With Ileostomy and Colostomy

Coloplast A/S·interventional·Posted Jan 23, 2014·Updated May 4, 2016

In Brief

A clinical study evaluating Coloplast Test, Own product, and 1 other intervention for Stoma Ileostomy and Stoma Colostomy. Completed, enrolled 38 participants across 1 site.

Detailed Summary

The aim of the investigation was to investigate the performance and safety of a new ostomy product

Study Details

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

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 23, 2014
Enrollment StartJan 1, 2014
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.4 years ago

Interventions

Coloplast Testdevice

Newly developed 1-piece convex ostomy product

Own productdevice

The subjects Own product is used as baseline performance in this investigation. The products are commercial and available on the market, and are products manufactured by manufactures who produce convex ostomy products i.e. Coloplast, Convatec, Dansac, B.Braun, Hollister and more.

Competitor soft convexdevice

A commercially available soft convex product