CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 79 enrolled
Drug / intervention
Non-Conformité Européene marked 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/NCT04101318
NCT04101318N/ACompleted
CompareCT.gov

Investigation of a New Stoma Product for People With a Stoma

Coloplast A/S·interventional·Posted Sep 24, 2019·Updated Sep 21, 2023

In Brief

A clinical study evaluating Non-Conformité Européene marked product and Conformité Européene marked competitor products for Peristomal Skin Complication. Completed, enrolled 79 participants across 1 site.

Detailed Summary

The CP288 study is an investigation of a non-Conformité Européene marked stoma product which will be conducted in the UK, Italy, Netherlands, Germany, and Norway. The study will enroll up to 100 subjects. The study is a randomized, open-label, comparative study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeristomal Skin Complication
CountriesNorway
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 24, 2019
Enrollment StartJan 22, 2020
Primary CompletionJul 17, 2020
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.8 years ago

Interventions

Non-Conformité Européene marked productdevice

New Baseplate is not named at this point

Conformité Européene marked competitor productsdevice

The Conformité Européene marked competitor products are considered Standard of Care or products considered to be part of Standard of Care in coming years.