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Investigation of Patient Benefits With a New Supporting Ostomy Product in Patients With a Newly Stoma Formation

NCT05135754 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-08-21

Study results available
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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.

Conditions

  • Stoma Ileostomy
  • Stoma Colostomy

Interventions

DEVICE

Heylo

Test of the supporting product (test product) for a 12 weeks period. No additional intervention will be conducted. A few follow up nurse calls to assess few endpoints together with subject. All remaining endpoints are captured via surveys send to the subjects every 14 days.

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Richard Brady · Newcastle-upon-Tyne Hospitals NHS Trust

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-25
Primary Completion
2022-08-22
Completion
2022-08-22

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05135754 on ClinicalTrials.gov