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Evaluation of a Novel Medical Device to Facilitate Gel Instillation During Change of Long-term Urinary Catheters

NCT03289117 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-10-20

No results posted yet for this study

Summary

A randomized, open label, controlled, parallel group study to investigate difference between regional standard procedure and a novel modified procedure (using an additional novel device to facilitate gel installation) for changing long-term indwelling urinary catheters.

Conditions

  • Urinary Catheters
  • Retention, Urinary
  • Incontinence, Urinary
  • Anesthesia, Local

Interventions

DEVICE

Novel gel installation device procedure

Catheter change with novel device Each subject will undergo catheter change with novel gel instillation device

DEVICE

Standard procedure

Catheter change with standard procedure Each subject will undergo catheter change with standard procedure

Sponsors & Collaborators

  • Lund University

    collaborator OTHER

  • Vinnova

    collaborator OTHER_GOV

  • Innovation Skåne AB/ Sweden

    collaborator UNKNOWN

  • Region Skane

    lead OTHER

Principal Investigators

  • Ulf Malmqvist, PhD · Clinical Studies Sweden - Forum South

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-17
Primary Completion
2017-05-26
Completion
2017-05-26

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 NCT03289117 on ClinicalTrials.gov