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Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy

NCT02675634 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2017-10-16

Study results available
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Summary

This clinical investigation is intended to explore the performance and safety of two newly developed ostomy products with regard to the products fit to body properties.

Conditions

  • Ileostomy
  • Colostomy

Interventions

DEVICE

Coloplast Test A

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

DEVICE

Coloplast Test B

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

DEVICE

Subjects own product

The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Camilla F Vibjerg · Head of Clinical Operation

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States
  • Denmark
  • 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 NCT02675634 on ClinicalTrials.gov