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

August 27, 2025 updated by: Coloplast A/S
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Humlebæk, Denmark
        • Recruiting
        • Coloplast A/S
        • Contact:
          • Thomas Krarup Simonsen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Outside this investigation, stoma patients eligible for the Heylo™ device prescription, will be onboarded to Heylo™ by stoma care nurses.

Subjects for this study will be identified through their Heylo™ app activation. A minimum of 100 subjects will be enrolled.

Description

Inclusion Criteria:

  1. Are you at least 18 years old? [Yes/No]
  2. Do you have an ileostomy or a colostomy? [Yes/No]
  3. Have you used Heylo™ for less than seven days? [Yes/No]

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary endpoint
Time Frame: one year
Stoma-related QoL measured by the Emotional Leakage Impact score (domain 1 of OLI) at baseline (0 months), 6, 9 and 12 months
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coloplast A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 2, 2027

Study Registration Dates

First Submitted

July 2, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 14, 2024

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • CP370

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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