Prospective Longitudinal Study of Heylo™ for People Living With a Stoma
Coloplast A/S
100 participants
Jul 1, 2024
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- Are you at least 18 years old? \[Yes/No\]
- Do you have an ileostomy or a colostomy? \[Yes/No\]
- Have you used Heylo™ for less than seven days? \[Yes/No\]
Exclusion Criteria1
- \) Do you have a stoma reversal planned (surgery date within the next 6 months)? Yes/No\]
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Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06554015