NCT05200416

Investigation of Heylo, a Novel App Driven Digital Supporting Ostomy Product

A Randomized Cross-over Trial Investigating Heylo, a Novel App Driven Digital Supporting Ostomy Product

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

People with intestinal stomas 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 called Heylo™, which has an adhesive sensor layer that should be placed underneath the baseplate. The sensor layer consists of an electronic sensor system that continuously detects moisture and output leakage underneath the baseplate. A transmitter connected to the sensor layer continuously evaluates the incoming information and sends a status to a smartphone software application, which based on a predefined flow decides which information to deliver to the user about the baseplate status. The overall aim of this clinical investigation is to evaluate the benefits of the new supporting product, Heylo compared to Standard of Care.

Detailed description

The Investigational device - Heylo, is already CE-marked. The investigation is an open-labelled, randomized cross-over trial with two test periods evaluating Heylo and Standard of Care. In total 144 subjects having an ileostomy or an colostomy will be included and randomized.

Conditions

• Ileostomy - Stoma
• Colostomy Stoma

Interventions

Type	Name	Description
DEVICE	Heylo	Heylo is used in combination with the ostomy baseplate usually used by the subjects. It will detect and notify the subject of the occurrence of output leakage under an ostomy baseplate.
DEVICE	Standard of Care	Standard of Care is the ostomy products (baseplate and bag) that the subject normally uses

Timeline

• Start date: 2022-01-13
• Primary completion: 2022-11-04
• Completion: 2022-11-04
• First posted: 2022-01-20
• Last updated: 2025-01-23
• Results posted: 2025-01-23

Locations

1 site across 1 country: Germany