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RECRUITING
NCT06554015

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

Sponsor: Coloplast A/S

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2024-07-01

Completion Date

2027-07-02

Last Updated

2025-09-04

Healthy Volunteers

No

Conditions

Locations (1)

Coloplast A/S

Humlebæk, Denmark