Trials / Recruiting
RecruitingNCT06554015
Prospective Longitudinal Study of Heylo™ for People Living With a Stoma
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- Coloplast A/S · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2024-07-01
- Primary completion
- 2026-07-01
- Completion
- 2027-07-02
- First posted
- 2024-08-14
- Last updated
- 2025-09-04
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT06554015. Inclusion in this directory is not an endorsement.