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Completed

NCT Number: NCT05200416

Investigation of 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.

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Key information

Conditions

Ileostomy - Stoma Colostomy Stoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peter C. Ambe

Bergisch Gladbach, Bergisch Gladbach,Nordrhein-Westfalen, 51429, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heylo

Device

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.

Standard of care

Device

Standard of Care is the ostomy products (baseplate and bag) that the subject normally uses

Primary outcomes

  1. Emotional Impact Score (Scale From 0-100)

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. Participation in Society Domain Score (Scale From 0-100)

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 20, 2022
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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