This record was last updated September 4, 2025 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History
1 amendment
This ClinicalTrials.gov record has been amended once since 2024-08-12.