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
This trial does not accept healthy volunteersQualifiers
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 population
Outside this investigation, stoma patients eligible for the Heylo™ device prescription, will be onboarded to Heylo™ by stoma care nurses. Subjects for this study will be identified through their Heylo™ app activation. A minimum of 100 subjects will be enrolled.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Primary endpoint
Stoma-related QoL measured by the Emotional Leakage Impact score (domain 1 of OLI) at baseline (0 months), 6, 9 and 12 months
Time frame
one yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov