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Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy

NCT02362360 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2016-10-11

Study results available
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Summary

The purpose of this study is to investigate the influence of a new ostomy product on the peristomal fit for people with an ileo- or colostomy.

Conditions

  • Ileostomy
  • Colostomy

Interventions

DEVICE

Coloplast Test Product

A new 2-piece ostomy appliance developed by Coloplast A/S

DEVICE

Comparator (Hollister)

Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag.

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Denmark
  • Germany
  • Netherlands
  • 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 NCT02362360 on ClinicalTrials.gov