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Investigation of a New Stoma Product for People With a Stoma

NCT04101318 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2023-09-21

Study results available
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Summary

The CP288 study is an investigation of a non-Conformité Européene marked stoma product which will be conducted in the UK, Italy, Netherlands, Germany, and Norway. The study will enroll up to 100 subjects. The study is a randomized, open-label, comparative study.

Conditions

  • Peristomal Skin Complication

Interventions

DEVICE

Non-Conformité Européene marked product

New Baseplate is not named at this point

DEVICE

Conformité Européene marked competitor products

The Conformité Européene marked competitor products are considered Standard of Care or products considered to be part of Standard of Care in coming years.

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Nazarena Mazzarro, MD · Coloplast A/S

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-22
Primary Completion
2020-07-17
Completion
2020-07-17

Countries

  • Norway

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 NCT04101318 on ClinicalTrials.gov