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Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy

NCT01994876 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2014-04-07

Study results available
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Summary

To investigate the performance and safety of two newly developed convex 1-piece ostomy appliances

Conditions

  • Ileostomy - Stoma

Interventions

DEVICE

Coloplast Test 1

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

DEVICE

Coloplast Test 2

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

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Kalid S Abd-Elaziz, MD · QPS Holdings LLC

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
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 NCT01994876 on ClinicalTrials.gov