MedTrace Logo

Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy

NCT01994902 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2016-01-12

Study results available
· View outcomes & findings →

Summary

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

Conditions

  • Stoma Ileostomy

Interventions

DEVICE

Coloplast test product

The Coloplast test product is a newly developed ostomy appliance

DEVICE

SenSura Convex Light

The comparator product is SenSura Convex Light, which is CE-marked and commercially available.

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Daniel Carter · 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
2013-11-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Denmark
  • France
  • Germany
  • Norway
  • United Kingdom

Study Locations

More Related Trials

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 NCT01994902 on ClinicalTrials.gov