Actively Recruiting
Prospective Longitudinal Study of Heylo™ for People Living With a Stoma
Led by Coloplast A/S · Updated on 2025-09-04
100
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Prospective Longitudinal Study of Heylo™ for People Living With a Stoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Have an ileostomy or a colostomy
- Have used the Heylo™ device for less than seven days
You will not qualify if you...
- Have a stoma reversal surgery planned within the next 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Coloplast A/S
Humlebæk, Denmark
Actively Recruiting
Research Team
T
Thomas Krarup Simonsen
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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