Investigation of Heylo, a Novel App Driven Digital Supporting Ostomy Product

A Randomized Cross-over Trial Investigating Heylo, a Novel App Driven Digital Supporting Ostomy Product

People with intestinal stomas can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively.

To overcome this, Coloplast has developed a new supporting ostomy product called Heylo™, which has an adhesive sensor layer that should be placed underneath the baseplate. The sensor layer consists of an electronic sensor system that continuously detects moisture and output leakage underneath the baseplate. A transmitter connected to the sensor layer continuously evaluates the incoming information and sends a status to a smartphone software application, which based on a predefined flow decides which information to deliver to the user about the baseplate status.

The overall aim of this clinical investigation is to evaluate the benefits of the new supporting product, Heylo compared to Standard of Care.

Study Overview

• Status: Completed
• Conditions: Ileostomy - Stoma; Colostomy Stoma
• Intervention / Treatment: Device: Heylo; Device: Standard of Care

Detailed Description

The Investigational device - Heylo, is already CE-marked.

The investigation is an open-labelled, randomized cross-over trial with two test periods evaluating Heylo and Standard of Care.

In total 144 subjects having an ileostomy or an colostomy will be included and randomized.

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bergisch Gladbach,Nordrhein-Westfalen
    • Bergisch Gladbach, Bergisch Gladbach,Nordrhein-Westfalen, Germany, 51429
      • Peter C. Ambe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Has given written consent to participate by signing the Informed Consent Signature Form.
• Is at least 18 years of age and has full legal capacity.
• Has an ileostomy or colostomy with consistent liquid/mushy fecal output (5-7 Bristol scale*)
• Is able to use one of the five test products (i.e. Ø40, Ø50, Ø60, Ø70, Ø80 mm).
• Has experienced leakage** under the baseplate at least three times within the last fourteen days. **Leakage defined as output seeping under the baseplate"
• Has worry about leakage to "some degree, high degree, or very high degree" (on a five-point Likert scale: Very low degree/Not at all, Low degree, some degree, High degree, very high degree)
• Is willing to refrain from use of ostomy paste.
• Has a smartphone compatible with the Heylo™ application
• Is able to follow study procedures for 4 months (assessed by investigator or delegate)

Exclusion Criteria:

• Is participating in other clinical investigations or has previously participated in this investigation
• Is pregnant or breastfeeding
• Has known hypersensitivity towards any of the products used in the investigation
• Is using/ has a pacemaker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Product - Heylo; The arm includes the test product Heylo	Device: Heylo; Heylo is used in combination with the ostomy baseplate usually used by the subjects. It will detect and notify the subject of the occurrence of output leakage under an ostomy baseplate.; Device: Standard of Care; Standard of Care is the ostomy products (baseplate and bag) that the subject normally uses
Active Comparator: Standard of Care; The arm includes Standard of Care	Device: Heylo; Heylo is used in combination with the ostomy baseplate usually used by the subjects. It will detect and notify the subject of the occurrence of output leakage under an ostomy baseplate.; Device: Standard of Care; Standard of Care is the ostomy products (baseplate and bag) that the subject normally uses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional Impact Score (Scale From 0-100)	Measured by the validated OLI scale evaluated at the end of each test period. The questionnaire regarding Emotional impact contains 10 questions where the 4 answer options are: All of the time, Often, Sometimes and Rarely or never, which can be converted into a combined numerical score. The scale ranges from 0-100, where a score of 100 equals no impact and a score of 0 represents full impact.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation in Society Domain Score (Scale From 0-100)	Measured by WHODAS 2.0 evaluated at the end of each test period. The questionnaire regarding Participation in society contains 11 questions where the 5 answer options are: None, Mild, Moderate, Severe and Extreme or cannot do, which can be converted into a combined domain score. Each domain has a range of 0-100, where low scores equal better health and high scores indicate greater disability.	8 weeks

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Peter C. Ambe, Dr.med, GFO Kliniken Rhein Berg, Vinzenz Pallotti Hospital, 51429 Bergisch Gladbach-Bensberg, Germany

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2022
• Primary Completion (Actual): November 4, 2022
• Study Completion (Actual): November 4, 2022

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: January 7, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CP345

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No