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Investigating the Safety and Performance of Two New 1-piece Ostomy Products Compared With SenSura 1-piece

NCT01957488 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2020-09-10

Study results available
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Summary

The aim of the current investigation is to investigate the performance of two new 1-piece ostomy products

Conditions

  • Ileostomy - Stoma

Interventions

DEVICE

Coloplast Test Product 1

Coloplast Test product 1 is a newly developed 1-piece ostomy appliance

DEVICE

Coloplast Test Product 2

Coloplast Test product 2 is a newly developed 1-piece ostomy appliance

DEVICE

Coloplast SenSura

SenSura 1-piece is the commercial available CE-marked SenSura 1-piece from Coloplast A/S.

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
2013-07-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Denmark
  • Netherlands
  • Norway
  • 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 NCT01957488 on ClinicalTrials.gov