Prospective Longitudinal Study of Heylo™ for People Living With a Stoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Stoma Ileostomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Primary endpoint [Time frame: one year]
Eligibility criteria
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
1\) Do you have a stoma reversal planned (surgery date within the next 6 months)? Yes/No\]
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Denmark · 1 center
- Coloplast A/S — Humlebæk
Publications
- 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
Identifiers
NCT: NCT06554015 · CP370