At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Cross-over Trial Investigating Heylo, a Novel App Driven Digital Supporting Ostomy Product
In Brief
A clinical study evaluating Heylo and Standard of Care for Ileostomy - Stoma and Colostomy Stoma. Completed, enrolled 144 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
Standard of Care is the ostomy products (baseplate and bag) that the subject normally uses