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Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care

NCT01957384 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2014-03-27

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. The degree of leakage using the product will also be measured

Conditions

  • Ileostomy - Stoma

Interventions

DEVICE

Coloplast Test product 1

Coloplast Test product 1 is a new ostomy appliance developed by Coloplast.

DEVICE

Coloplast Test product 2

Coloplast Test product 2 is a new ostmoy appliance developed by Coloplast A/S

DEVICE

Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)

Standard Care was the subject usual ostomy appliance and had to be one of the following: * Coloplast: SenSura, 1-piece open bag without inspection window, size midi and maxi, custom-cut, * Dansac: Nova 1 \& Nova Life, 1-piece open bag, size midi and maxi, custom-cut baseplate * Hollister: Moderma Flex, 1-piece open, size midi and maxi, custom-cut baseplate * ConvaTec: Esteem, 1-piece open bag, size midi and maxi, custom-cut baseplate * B. Braun: Flexima Active \& Softima, 1-piece open bag, size midi and maxi, custom-cut baseplate

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Birte Petersen · Coloplast A/S

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-05-31
Completion
2012-05-31

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 NCT01957384 on ClinicalTrials.gov