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Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care

NCT01517178 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2015-03-13

Study results available
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Summary

The primary object of this study is to provide clinical documentation for the New base plate significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care base plates.

The secondary objectives are to provide clinical documentation on several performance and safety parameters on the New base plate compared to Standard Care base plates.

The primary hypothesis is that the New base plate significantly reduces degree of leakage under the base plate compared to Standard Care base plates.

Each test period will last for two weeks. In addition to this there will be one week run-in period on New base plate. The data will be collected by investigator in the Case Report Form at the inclusion visit, cross-over visit and termination visit. Data will also be collected by the subject in a questionnaire during the two test periods.

The subjects will change their base plates on per need basis and continue with their normal changing pattern in the entire study period.

100 subjects with ileostomy will be included in the study. The subjects will be recruited from Europe including Denmark, Norway, Sweden, Iceland, Germany and France.

Conditions

  • Leakage
  • Skin Condition

Interventions

DEVICE

New ostomy base plate (SS)

The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.

DEVICE

Standard Care base plate

The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Denmark
  • France
  • Germany
  • Iceland

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 NCT01517178 on ClinicalTrials.gov