CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 32 enrolled
Drug / intervention
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/NCT01799239
NCT01799239N/ACompleted
CompareCT.gov

Investigating the Safety and Performance of Newly Developed 1-piece Ostomy Product Concept Compared With SenSura 1-piece in Subjects With an Ileostomy

Coloplast A/S·interventional·Posted Feb 26, 2013·Updated Sep 30, 2016

In Brief

A clinical study evaluating Test product and SenSura for Ileostomy - Stoma. Completed, enrolled 32 participants across 1 site.

Detailed Summary

The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIleostomy - Stoma
CountriesSweden
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 26, 2013
Enrollment StartFeb 1, 2013
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 13.3 years ago

Interventions

Test productdevice

The test product consists of an adhesive with a new top film

SenSuradevice

SenSura is the CE-marked and commercially available comparator product