Clinical Investigation of an Improved Two-piece Stoma Product for People Living With a Stoma — CP343  

Stoma Site Leakage Clinical Trial

Official title: A Randomized, Controlled Clinical Investigation of an Improved Two-piece Stoma Product for People Living With a Stoma

Status Completed

Clinical Trial Summary

Open-label, randomized, controlled, comparative, cross-over study with 2 test sequences comparing a new 2p coupling system with SenSura Mio Click.

Clinical Trial Description

Open-label, randomized, controlled, comparative, cross-over study with 2 test sequences comparing a new 2p coupling system with SenSura Mio Click. Each test period is 3 weeks (± 2 days), total study period is 6 weeks (± 4 days). It will be a 1:1 randomization into the two possible treatment sequences.

The investigation will require 50 randomized subjects (exp. 20% drop-out), leading to at least 40 completed subjects. The sample size calculation is based on at least 6 bag changes during each test period (≥2 chang-es per week).

All visits will be performed as remote virtual calls. At the visits, the investigator (or designee) will give in-structions for the coming period and check that the trial is running as planned. At every bag change the sub-ject will be asked to complete a questionnaire. ;

Related Conditions & MeSH terms

• Stoma Site Leakage

• NCT number: NCT05652010
• Study type: Interventional
• Source: Coloplast A/S
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Completion date: August 21, 2023