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

Recruiting

• Conditions: Stoma Ileostomy

• Registration Number: NCT06554015
• Lead Sponsor: Coloplast A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-01
• Study First Submitted: 2024-07-02
• Study First Submitted QC: 2024-08-12
• Last Update Submitted: 2024-08-12
• Study First Posted: 2024-08-14
• Last Update Posted: 2024-08-14
• Primary Completion: 2025-07-01
• Study Completion: 2027-07-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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]

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint	one year	Stoma-related QoL measured by the Emotional Leakage Impact score (domain 1 of OLI) at baseline (0 months), 6, 9 and 12 months

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebæk, Denmark