A Clinical Investigation of New Ostomy Appliances

Leakage Clinical Trial

Official title:
An Open-labelled Randomized Cross-over and Controlled Exploratory Investigation Comparing Several Variants of a Newly Developed Ostomy Appliance With Regard to Performance in 20 Patients With Ileostomy

Status Completed

Clinical Trial Summary

This is an open-labelled randomized cross-over and controlled exploratory intervention that aims to include 20-30 patients with an ileostomy. Every patient is to test two new ostomy appliances each for two weeks. During the test a questionaire is to be filled out and interviews will take place. Primary parameter is leakage. A Study nurse will visit the participants in their homes every two week during the test.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Leakage

Clinical Trial Details

NCT number	NCT01523756
Study type	Interventional
Source	Coloplast A/S
Contact
Status	Completed
Phase	N/A
Start date	February 2012
Completion date	April 2012

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT01448629` - Safety and Performance of a New 1-piece Ostomy Product Compared to Standard Care Ostomy Products in Subjects Ileostomy	N/A
Terminated	`NCT01517178` - Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care	Phase 3
Not yet recruiting	`NCT06310070` - 3D Printed Personalized Ostomy Appliance	N/A
Completed	`NCT01784458` - Clinical Significance of Intra-abdominal Hypertension in Surgical Patients With Severe Sepsis	N/A
Completed	`NCT05147870` - Outcome After Laparoscopic Surgery for Peptic Ulcer Perforation