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

NCT05200416 | Completed Results

• 1 other identifier: CP345
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ileostomy - Stoma; Colostomy Stoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  8 weeks

Study Arms (2)

Test Product - Heylo

EXPERIMENTAL

The arm includes the test product Heylo

Device: Heylo; Device: Standard of Care

Standard of Care

ACTIVE COMPARATOR

The arm includes Standard of Care

Device: Heylo; Device: Standard of Care

Interventions

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; Test Product - Heylo

Standard of Care DEVICE

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

Standard of Care; Test Product - Heylo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Peter C. Ambe

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

Location

Related Publications (1)

• Ambe PC, Brunckhorst E, Hansen HD, Gotfredsen JL, Vestergaard M, Ajslev TA. Effect of a Novel Digital Leakage Notification System (Heylo) for Ostomy Care on Quality of Life and Burden of Living With an Intestinal Ostomy: The ASSISTER Trial, A Randomized Controlled Cross-Over Trial. Mayo Clin Proc Digit Health. 2023 Sep 1;1(3):438-449. doi: 10.1016/j.mcpdig.2023.06.013. eCollection 2023 Sep.

  PMID: 40206623 DERIVED

Results Point of Contact

• Title: Senior Clinical Strategy Project Manager
• Organization: Coloplast A/S

dkteaa@coloplast.com

+4549111341

Study Officials

• Peter C. Ambe, Dr.med

  GFO Kliniken Rhein Berg, Vinzenz Pallotti Hospital, 51429 Bergisch Gladbach-Bensberg, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: January 20, 2022
• Study Start: January 13, 2022
• Primary Completion: November 4, 2022
• Study Completion: November 4, 2022
• Last Updated: January 23, 2025
• Results First Posted: January 23, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)