Long-Term Study of Heylo Digital Leakage Notification System for Adults Living With an Intestinal Stoma

What this Trial Is About

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 AS and involves ongoing observation without additional interventions or treatments.

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