CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 55 enrolled
Drug / intervention
Coloplast Test A +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/NCT02675634
NCT02675634N/ACompleted
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Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy

Coloplast A/S·interventional·Posted Feb 5, 2016·Updated Oct 16, 2017

In Brief

A clinical study evaluating Coloplast Test A, Coloplast Test B, and 1 other intervention for Ileostomy and Colostomy. Completed, enrolled 55 participants across 12 sites in 4 countries.

Detailed Summary

This clinical investigation is intended to explore the performance and safety of two newly developed ostomy products with regard to the products fit to body properties.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIleostomy, Colostomy
CountriesDenmark, Netherlands, United Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 5, 2016
Enrollment StartJan 1, 2016
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.4 years ago

Interventions

Coloplast Test Adevice

Test A is a new 1-piece ostomy appliance developed by Coloplast A/S

Coloplast Test Bdevice

Test B is a new 1-piece ostomy appliance developed by Coloplast A/S

Subjects own productdevice

The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.