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Investigation of a Supporting Ostomy Product Intended for Leakage Detection

NCT04894084 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-09-22

Study results available
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Summary

People with intestinal stomas (especially an ileostomy) 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, which has an adhesive sensor layer that should be place underneath the baseplate normally used by the subject.

Single arm design. Open-labelled Study duration: 21 days + 3 days.

Conditions

  • Stoma Ileostomy

Interventions

DEVICE

CP321

The primary objective is to evaluate the system performance of the test product. This is done by asking subjects to answer questions throughout the study

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Søren Meisner, MD · Coloplast A/S

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
2021-04-29
Primary Completion
2021-07-14
Completion
2021-07-14

Countries

  • Denmark

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 NCT04894084 on ClinicalTrials.gov