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Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece in Subjects With Ileostomy

NCT01994863 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2015-03-11

Study results available
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Summary

The objective of the investigation is to document New Mio 1-piece is non-inferior (no worse) in reducing leakage (4-point scale) compared to Standard of Care.

Conditions

  • Ileostomy - Stoma

Interventions

DEVICE

Coloplast Test product

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

DEVICE

Standard Care

Standard care consists of three already marketed 1-piece ostomy products Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Daniel Carter, MSc · Coloplast A/S

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • Netherlands

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 NCT01994863 on ClinicalTrials.gov