MedTrace Logo

Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece

NCT01957553 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2014-09-08

Study results available
· View outcomes & findings →

Summary

The aim of the current investigation is to investigate the performance of a new 2-piece ostomy product

Conditions

  • Ileostomy - Stoma

Interventions

DEVICE

Coloplast test product

Coloplast test product is a newly developed 2-piece ostomy appliance

DEVICE

SenSura

SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance 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
2013-09-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Belgium
  • Denmark
  • Netherlands
  • Norway
  • Sweden

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 NCT01957553 on ClinicalTrials.gov