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A Clinical Investigation Examining the Performance and Handling of New 2-piece Ostomy Products in 28 People With an Ileostomy.

NCT02064231 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2020-09-10

Study results available
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Summary

To assess the functionality and safety of the test products and also assess the products ability to collect stool without interfering with the stoma.

Conditions

  • Ileostomy - Stoma

Interventions

DEVICE

Coloplast Test A

Coloplast Test A is a new ostomy appliance developed by Coloplast A/S

DEVICE

Coloplast Test B

Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S

DEVICE

Own product

Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.

DEVICE

Coloplast Test C

Coloplast Test C is a new ostomy appliance developed by Coloplast A/S

DEVICE

Coloplast Test D

Coloplast Test D is a new ostomy appliance developed by Coloplast A/S

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Birte p Jakobsen, MD · Medical director

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2012-08-31
Completion
2012-08-31

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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 NCT02064231 on ClinicalTrials.gov