NCT00802750

Study Where Healthy Volunteers Evaluate LoFric Catheters

A Randomized, Single-blind, Cross-over, Single Centre Study in Healthy Volunteers Evaluating Subject Perception of Urinary Catheters Manufactured in a New Process With New Solvent

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Wellspect HealthCare · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate healthy volunteers perception of catheterization with LoFric catheters with new solvents in the manufacturing process. The subjects will be catheterized three times during one visit day. The hypothesis is that the subjects' perception of catheterization is the same when using the test catheters compared to the reference catheter.

Conditions

• Catheterization

Interventions

Type	Name	Description
DEVICE	LoFric POBE	LoFric POBE, Nelaton 40 cm, CH 12 with new solvent. Each subject will use the reference catheter "LoFric POBE, Nelaton 40 cm, CH 12 with current solvent" before being catheterized with the test catheters.
DEVICE	LoFric POBE	Unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with new solvent Each subject will use the reference catheter "LoFric POBE, Nelaton 40 cm, CH 12 with current solvent" before being catheterized with the test catheters.

Timeline

• Start date: 2008-11-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-12-05
• Last updated: 2021-02-05

Locations

1 site across 1 country: Sweden