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Prospective Longitudinal Study of Heylo™ for People Living With a Stoma
Sponsor: Coloplast A/S
Summary
This study aims to longitudinally evaluate the usage and long-term benefits of the CE-marked device, Heylo™, a digital leakage notification system for people with intestinal stomas. The system, which includes a smartphone application, an adhesive sensor layer, and a Bluetooth transmitter, notifies users of changes in their baseplate status, potentially reducing stoma effluent leakage and improving quality of life. The physical Heylo™ device, is part of the Coloplast Charter telehealth service.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2024-07-01
Completion Date
2027-07-02
Last Updated
2025-09-04
Healthy Volunteers
No
Conditions
Locations (1)
Coloplast A/S
Humlebæk, Denmark