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Evaluation of a New Catheter Coating Process for Urinary Catheters Used for Intermittent Catheterization.

NCT03684941 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-12-05

No results posted yet for this study

Summary

This is a prospective, double-blinded, randomized, multi-centre, cross-over study. All subjects will use both the study device (test catheter) and the comparator (control catheter) for one week each.

Conditions

  • Intermittent Urethral Catheterization

Interventions

DEVICE

Treatment Period One

LoFric Origo urinary catheter, 40-cm length, CH12/CH14 diameter, with Nelaton tip

DEVICE

Treatment Period Two

CE-marked LoFric Origo urinary catheter, 40-cm length, CH12/CH14 diameter, with Nelaton tip

Sponsors & Collaborators

  • Wellspect HealthCare

    collaborator INDUSTRY

  • Dentsply International

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-29
Primary Completion
2018-11-19
Completion
2018-11-19

Countries

  • Sweden

Study Locations

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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 NCT03684941 on ClinicalTrials.gov