NCT04101318

Investigation of a New Stoma Product for People With a Stoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Enrolled participant with an ileostomy or colostomy with liquid output were randomized to test either the non-Conformité Européene marked investigational product or one of the five comparators Conformité Européene marked products first and then will be crossed over to receive the opposite intervention. The participant will first be included in an information and inclusion visit (V0) and after signing all consent forms will complete three test visits (V1, V2, and V3). Each participant will be enrolled for 2 × 42±3 days in total for the entire investigation, thus for a maximum of 90 days. The study is a randomised, controlled, open-label, comparative, cross-over, multicentre investigation with two test periods. The study was conducted in four different countries (UK, Germany, Italy, and Norway) with a total of six sites participating. The study is now complete.

Conditions

• Peristomal Skin Complication

Interventions

Type	Name	Description
DEVICE	Non-Conformité Européene marked product	New Baseplate is not named at this point
DEVICE	Conformité Européene marked competitor products	The Conformité Européene marked competitor products are considered Standard of Care or products considered to be part of Standard of Care in coming years.

Timeline

• Start date: 2020-01-22
• Primary completion: 2020-07-17
• Completion: 2020-07-17
• First posted: 2019-09-24
• Last updated: 2023-09-21
• Results posted: 2023-09-21

Locations

1 site across 1 country: Norway