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RecruitingNCT06554015Updated Sep 4, 2025

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

An observational study in Stoma Ileostomy, sponsored by Coloplast A/S. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-04.

Sponsored by Coloplast A/S · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 4 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Stoma Ileostomy
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In context

Lead sponsor

Coloplast A/S is the lead sponsor of 150 studies on the registry; 8 are open to participants now.

Browse Coloplast A/S studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
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What researchers measure

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

    Time frame: one year

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Study locations

1 of 1 sites recruiting
  • Coloplast A/S
    Humlebæk, Denmark
    Recruiting
    • Thomas Krarup Simonsen · Contact
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References and documents

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. PubMed 41598602 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2024 (actual). Primary completion is estimated for Jul 2026, 24 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 2, 2024
First posted
Aug 14, 2024
StartActual
Jul 1, 2024
Primary completionEst.
Jul 1, 2026
CompletionEst.
Jul 2, 2027
Last update
Sep 4, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06554015
Lead sponsor
Coloplast A/S
Responsible party
Sponsor
First posted
Aug 14, 2024
Start date
Jul 1, 2024
Primary completion
Jul 1, 2026 (estimated)
Completion
Jul 2, 2027 (estimated)
Last update
Sep 4, 2025

Study contacts

Thomas Krarup Simonsen
Contact
dktksi@coloplast.com
+4549111873

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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