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Investigation of a New 1-piece Convex Ostomy Product

NCT02043782 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2016-05-04

Study results available
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Summary

The aim of the investigation was to investigate the performance and safety of a new ostomy product

Conditions

  • Stoma Ileostomy
  • Stoma Colostomy

Interventions

DEVICE

Coloplast Test

Newly developed 1-piece convex ostomy product

DEVICE

Own product

The subjects Own product is used as baseline performance in this investigation. The products are commercial and available on the market, and are products manufactured by manufactures who produce convex ostomy products i.e. Coloplast, Convatec, Dansac, B.Braun, Hollister and more.

DEVICE

Competitor soft convex

A commercially available soft convex product

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Birte P Jakobsen, MD · Coloplast A/S

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-04-30
Completion
2014-04-30

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 NCT02043782 on ClinicalTrials.gov