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Comparison of EVD Catheter Diameter on Occlusion and Replacement

NCT03248739 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2023-10-25

Study results available
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Summary

A randomized trial comparing small versus large catheters in terms of occlusion and need for replacement to confirm differential occlusion risk based on catheter size. This study will be done to determine whether external ventricular drain catheter diameter has any effect on risk of occlusion.

Conditions

  • Occlusion

Interventions

DEVICE

Clear Bactiseal 'large' catheter (EVD)

Antibiotic-impregnated 'large' catheter (inner diameter 1.9 mm, outer diameter 3.4 mm)

DEVICE

Orange Bactiseal 'small' catheter (EVD)

Antibiotic-impregnated 'small' catheter (inner diameter 1.5 mm, outer diameter 3 mm)

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Kyle M Fargen, MD · Assistant Professor, Surgery Neurosurgery

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-12
Primary Completion
2022-11-04
Completion
2022-11-04
FDA Device
Yes

Countries

  • United States

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 NCT03248739 on ClinicalTrials.gov