CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 52 enrolled
Drug / intervention
Coloplast Test Product +1 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/NCT02362360
NCT02362360N/ACompleted

Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy

Coloplast A/S·interventional·Posted Feb 12, 2015·Updated Oct 11, 2016

In Brief

A clinical study evaluating Coloplast Test Product and Comparator (Hollister) for Ileostomy and Colostomy. Completed, enrolled 52 participants across 5 sites in 4 countries.

Detailed Summary

The purpose of this study is to investigate the influence of a new ostomy product on the peristomal fit for people with an ileo- or colostomy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIleostomy, Colostomy
CountriesDenmark, Germany, Netherlands, Norway
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 12, 2015
Enrollment StartFeb 1, 2015
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.4 years ago

Interventions

Coloplast Test Productdevice

A new 2-piece ostomy appliance developed by Coloplast A/S

Comparator (Hollister)device

Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag.