A Randomized Controlled Clinical Investigation Evaluating a Flat Ostomy Barrier With A Novel Skin Protection Technology

Authors Coloplast A/S -More
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2021
Links ClinicalTrials.gov
This investigation is a randomized, controlled, open-label, comparative, cross-over, multicenter investiga-tion, with two test periods. In total, 82 subjects will be included and randomized, and each subject will have three test visits overseen by the Principal Investigator, or designee. Each subject will be enrolled for 2 × 35 -1/+3 days in total for the entire investigation, thus approximately 70 days. The subjects will test the non-CE marked test product and the comparator product in randomized order.
Epistemonikos ID: eef9b9ef2bc33f6e78a6e3f4eedc24fe78f71a2b
First added on: May 08, 2024