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

Recruiting now

Conditions studied: Stoma Ileostomy

In brief

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 facts

Study ID

NCT06554015

Run by

Coloplast A/S

People needed

100

Starts

2024-07-01

Expected to finish

2027-07-02

Last updated by the study team

2025-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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]

You may not qualify if…

• Do you have a stoma reversal planned (surgery date within the next 6 months)? Yes/No]

Where it is running

• Coloplast A/S — Humlebæk, Denmark (enrolling)

Full record on ClinicalTrials.gov

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