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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Ileostomy - Stoma, Colostomy Stoma

Intervention / Treatment
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* Device: Heylo
* Device: Standard of Care


Participation Criteria
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Eligibility Criteria
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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 (as-sessed 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Product - Heylo<br>The arm includes the test product Heylo | Device: Heylo<br>* 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.<br>Device: Standard of Care<br>* Standard of Care is the ostomy products (baseplate and bag) that the subject normally uses<br>|
| Active Comparator: Standard of Care<br>The arm includes Standard of Care | Device: Heylo<br>* 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.<br>Device: Standard of Care<br>* Standard of Care is the ostomy products (baseplate and bag) that the subject normally uses<br>|

What is the study measuring?
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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. | 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. | 8 weeks |