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

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.

Recruiting

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Key information

Conditions

Stoma Ileostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Coloplast A/S

Humlebæk, Denmark

Location status: Recruiting

Location contact

Thomas Krarup Simonsen

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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]

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas Krarup Simonsen

CONTACT

[email protected]

+4549111873

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2027
First posted: Aug 14, 2024
Registry last updated: Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting