NCT04544566

A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An investigation of non-CE marked stoma tape products. This investigation is a randomised, open-label, comparative, cross-over study, with three test periods. In total, 12 subjects will be included and randomised.

Detailed description

The test products are non-CE marked stoma tape products. This investigation is a randomised, open-label, comparative, cross-over study, with three test periods. In total, 12 subjects will be included and randomised.

Conditions

• Stoma Site Leakage

Interventions

Type	Name	Description
DEVICE	Test product A	one new adhesive material which is applied to the baseplate and the subjects peristomal skin
DEVICE	Test product B	one new adhesive material which is applied to the baseplate and the subjects peristomal skin
DEVICE	Comparator	Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin

Timeline

• Start date: 2020-07-07
• Primary completion: 2020-08-21
• Completion: 2020-08-21
• First posted: 2020-09-10
• Last updated: 2021-05-06
• Results posted: 2021-05-06

Locations

1 site across 1 country: Denmark