CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Test product 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/NCT04544566
NCT04544566N/ACompleted
CompareCT.gov

A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin

Coloplast A/S·interventional·Posted Sep 10, 2020·Updated May 6, 2021

In Brief

A clinical study evaluating Test product A, Test product B, and 1 other intervention for Stoma Site Leakage. Completed, enrolled 12 participants across 1 site.

Detailed Summary

An investigation of non-CE marked stoma tape products. This investigation is a randomised, open-label, comparative, cross-over study, with three test periods. In total, 12 subjects will be included and randomised.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStoma Site Leakage
CountriesDenmark
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedSep 10, 2020
Enrollment StartJul 7, 2020
Primary CompletionAug 21, 2020
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 5.8 years ago

Interventions

Test product Adevice

one new adhesive material which is applied to the baseplate and the subjects peristomal skin

Test product Bdevice

one new adhesive material which is applied to the baseplate and the subjects peristomal skin

Comparatordevice

Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin