NCT04894084

Investigation of a Supporting Ostomy Product Intended for Leakage Detection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

People with intestinal stomas (especially an ileostomy) can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively. To overcome this, Coloplast has developed a new supporting ostomy product, which has an adhesive sensor layer that should be place underneath the baseplate normally used by the subject. Single arm design. Open-labelled Study duration: 21 days + 3 days.

Detailed description

Test product is a Digital Leakage Notification System. It consist of a sensor layer (worn beneath the baseplate), a transmitter attached to the sensor layer, a charger for charging of transmitter and an app, to be installed on a smartphone, which notifies the user of the status of their baseplate such as everything looks okay or there is a possible leakage. Subjects are asked to use test product for 21 days. n=15 were using a phone with Android operating system and n=10 a phone with iOS operating system.

Conditions

• Stoma Ileostomy

Interventions

Type	Name	Description
DEVICE	CP321	The primary objective is to evaluate the system performance of the test product. This is done by asking subjects to answer questions throughout the study

Timeline

• Start date: 2021-04-29
• Primary completion: 2021-07-14
• Completion: 2021-07-14
• First posted: 2021-05-20
• Last updated: 2023-09-22
• Results posted: 2023-08-01

Locations

1 site across 1 country: Denmark