Actively Recruiting
Led by Coloplast A/S · Updated on 2025-09-04
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are studying the long-term use and benefits of the Heylo™ device, a digital leakage notification system designed for people living with intestinal stomas such as ileostomy or colostomy. The device aims to alert users to changes in their stoma baseplate status, which may help reduce leakage and improve quality of life. The Heylo™ device is part of the Coloplast Charter telehealth service. The Heylo™ system includes a smartphone application, an adhesive sensor layer, and a Bluetooth transmitter that work together to notify users about their stoma care status. This observational study will follow participants over time to understand how they use the device and its potential long-term effects on managing stoma leakage. Participants will be monitored for at least one year, during which their usage of the Heylo™ device and its impact on stoma leakage and quality of life will be evaluated. The primary outcome measure is assessed at one year. The study is sponsored by Coloplast A/S and involves ongoing observation without additional interventions or treatments.
CONDITIONS
Prospective Longitudinal Study of Heylo™ for People Living With a Stoma
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 year
Participants living with a stoma and using the Heylo™ device are observed over time to evaluate outcomes.
Total: 1 location
1
Coloplast A/S
Humlebæk, Denmark
Actively Recruiting
T
Thomas Krarup Simonsen
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Martin Vestergaard, Amanda Gunning, Rebecca Mather...
https://pubmed.ncbi.nlm.nih.gov/41598602