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Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters

NCT02651337 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2020-09-21

Study results available
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Summary

The objective of this pilot study is to perform a set of pressure and flow rate measurements in order to quantitatively characterize safe irrigation or "flushing" of a ventricular shunt catheter, a routine maneuver performed by a neurosurgeon during a shunt revision surgery. This maneuver involves injecting saline with a syringe to clear plugged shunt catheters. Based on data obtained in Stage I of the study, a device has been fabricated which provides the same small-volume pulse of fluid used by surgeons. In Stage II of the study, pressure and flow rate measurements generated by this specialized flusher device will be collected and measured.

Conditions

  • Hydrocephaly

Interventions

DEVICE

Cerebrospinal Fluid (CSF) Drainage

Placement of Alivio in line flusher during CSF drainage

Sponsors & Collaborators

  • Alcyone Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Benjamin Warf, MD Warf, MD · Boston Children's Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Days
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-01
Primary Completion
2016-06-04
Completion
2016-06-14

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 NCT02651337 on ClinicalTrials.gov