Evaluating the Heylo™ device for people with stomas
Prospective Longitudinal Study of Heylo™ for People Living With a Stoma
This study is testing a new device that helps people with stomas by sending alerts to their phones when there are changes in their stoma bag, to see if it can reduce leaks and improve their daily life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Coloplast A/S Industry-sponsored |
| Locations | 1 site (Humlebæk) |
| Trial ID | NCT06554015 on ClinicalTrials.gov |
What this trial studies
This study evaluates the long-term benefits of the Heylo™ device, a digital leakage notification system designed for individuals with intestinal stomas. The device includes a smartphone application, an adhesive sensor layer, and a Bluetooth transmitter that alerts users to changes in their baseplate status. By potentially reducing leakage incidents, the study aims to improve the quality of life for stoma patients. Participants will be monitored over time to assess the effectiveness of the device in real-world settings.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have an ileostomy or colostomy and have used the Heylo™ device for less than seven days.
Not a fit: Patients who have a stoma reversal planned within the next six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance the quality of life for individuals living with stomas by reducing leakage incidents.
How similar studies have performed: While this approach is innovative, there is limited information on the success of similar studies specifically evaluating digital notification systems for stoma care.
Eligibility criteria
Show full inclusion / exclusion criteria
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: 1\) Do you have a stoma reversal planned (surgery date within the next 6 months)? Yes/No\]
Where this trial is running
Humlebæk
- Coloplast A/S — Humlebæk, Denmark (Recruiting)
Study contacts
- Study coordinator: Thomas Krarup Simonsen
- Email: dktksi@coloplast.com
- Phone: +4549111873
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.