MedTrace Logo

Safety and Performance of a New Coating for Urinary Intermittent Catheters

NCT01800903 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-09-10

Study results available
· View outcomes & findings →

Summary

The aim of the study is to evaluate safety and performance of a new catheter coating,compared to the current SpeediCath coating.

Conditions

  • Intermittent Urethral Catheterization

Interventions

DEVICE

ZN-D catheter

ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.

DEVICE

ZN-C catheter

ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.

DEVICE

SpeediCath catheter

The Speedicath cathere is CE-marked and commercially available.

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Per Bagi, MD, PhD · Department of Urology, Rigshospitalet Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Denmark

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 NCT01800903 on ClinicalTrials.gov