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Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy

NCT01800890 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2014-08-06

Study results available
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Summary

The aim of the current clinical investigation is to evaluate the performance and safety of new 2-piece ostomy product concepts.

Conditions

  • Subjects With an Ileostomy

Interventions

DEVICE

Coloplast A

Coloplast A is a newly developed 2-piece ostomy appliance

DEVICE

Coloplast B

Coloplast B is a newly developed 2-piece ostomy appliance

DEVICE

Coloplast C

Coloplast C is a newly developed 2-piece ostomy appliance

DEVICE

SenSura Click

The comparator product is the commercial and CE-marked SenSura Click (2-piece) manufactured by Coloplast A/S.

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Daniel Carter, MSc · 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
2013-02-28
Primary Completion
2013-04-30
Completion
2013-04-30

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 NCT01800890 on ClinicalTrials.gov