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

NCT06554015 | Recruiting

• 1 other identifier: CP370
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stoma Ileostomy

Outcome Measures

Primary Outcomes (1)

• Primary endpoint

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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\]

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Coloplast A/S

Humlebæk, Denmark

RECRUITING

Related Publications (1)

• Vestergaard M, Gunning A, Mather R, Hansen HD, Ajslev TA. Impact of a Digital Leakage Notification System on Leakage, Quality of Life, Healthcare Resource Utilisation, and Work Productivity: Interim Results from a Longitudinal Real-World Study in the UK. J Clin Med. 2026 Jan 14;15(2):663. doi: 10.3390/jcm15020663.

  PMID: 41598602 DERIVED

Central Study Contacts

Thomas Krarup Simonsen

CONTACT

+4549111873; dktksi@coloplast.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: August 14, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 2, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

DK (1)