Actively Recruiting

Age: 18Years +
All Genders
NCT06554015

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

Led by Coloplast A/S · Updated on 2025-09-04

100

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years old
  • Have an ileostomy or a colostomy
  • Have used the Heylo™ device for less than seven days
Not Eligible

You will not qualify if you...

  • Have a stoma reversal surgery planned within the next 6 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Coloplast A/S

Humlebæk, Denmark

Actively Recruiting

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Research Team

T

Thomas Krarup Simonsen

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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