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The Influence of Adhesive Wafer Design on Fit to the Body

NCT02176954 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-03-23

No results posted yet for this study

Summary

The aim of this study is to investigate the influence of the adhesive wafer design on the products ability to fit to the body..

Conditions

  • Ostomy - Ileostomy or Colostomy

Interventions

DEVICE

Test A

Test A is a new 1-piece ostomy appliance developed by Coloplast A/S

DEVICE

Test B

Test B is a new 1-piece ostomy appliance developed by Coloplast A/S

DEVICE

Comparator

Two comparators will be used: Moderma Flex (Hollister) or Confidence Natural drainable (Salts).These product are commercially available. Subjects will be randomized into one of twelwe arms. Data will be analyzed by pooling the two comparators, Moderma Flex and Confidence Natural, Drainable, why six arms are displayed.

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Khalid Abd-Elaziz, MD · QPS Netherlands

  • Susanne Eyre, MD · Synexus North East, United Kingdom

  • Gillian Hopkins · Cheltenham General Hospital, United Kingdom

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-02-28
Completion
2015-03-31

Countries

  • Netherlands
  • United Kingdom

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 NCT02176954 on ClinicalTrials.gov