Prospective Longitudinal Study of Heylo™ for People Living With a Stoma
ConditionStoma Ileostomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorColoplast A/S
About this trial
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 criteria
Qualifiers
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]
Disqualifiers
None
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Source ClinicalTrials.gov