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Prospective Longitudinal Study of Heylo™ for People Living With a Stoma

NCT06554015 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-09-04

No results posted yet for this study

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

  • Stoma Ileostomy

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2026-07-01
Completion
2027-07-02

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06554015 on ClinicalTrials.gov