CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 4 enrolled
Drug / intervention
Cerebrospinal Fluid (CSF) Drainagedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02651337
NCT02651337N/ACompleted
CompareCT.gov

Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters

Alcyone Therapeutics, Inc·interventional·Posted Jan 11, 2016·Updated Sep 21, 2020

In Brief

A clinical study evaluating Cerebrospinal Fluid (CSF) Drainage for Hydrocephaly. Completed, enrolled 4 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHydrocephaly
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 11, 2016
Enrollment StartApr 1, 2016
Primary CompletionJun 4, 2016
Study CompletionJun 14, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 10.5 years ago

Interventions

Cerebrospinal Fluid (CSF) Drainagedevice

Placement of Alivio in line flusher during CSF drainage