Guided Application of Ventricular Catheters

Failure of ventricular catheters remains a significant problem in patients with hydrocephalus. The purpose of this study is to determine whether the use of a simple instrument assisted by a smart phone application software can achieve a more precise placement of ventricular catheters than the standard free-hand placement technique.

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Key information

Conditions

Hydrocephalus Brain Diseases Central Nervous System Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité University Hospital, Division of Pediatric Neurosurgery, Berlin, Germany

About this study

Free-hand placement of ventricular catheters (VC) is reported to be inaccurate in 10-40%. Furthermore, there is evidence that the quality of VC positioning is correlating with the risk for proximal shunt obstruction. Ultrasound or neuronavigation are used in order to improve to placement. However, they are associated with significant technical efforts and increased time.

In this study a simple instrument assisted by a smart phone application software is used in order to achieve precise placement of ventricular catheters. The results are compared with the standard free-hand procedure. Patients requiring a ventricular catheter are randomized to one of the two treatments. The primary outcome parameter is a qualitative and quantitative assessment of the position of the ventricular catheter on a post-operative image. The evaluation of the primary criteria is performed by a radiologist blinded to the randomization arm.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients requiring a permanent ventricular catheter for the treatment of CSF (cerebrospinal fluid) - circulation disorder or another disease (ventricular shunt oder Ommaya/Rickham-Reservoir)
Frontal occipital horn ratio (FOHR) < 0.5
Use of a new puncture channel
Frontal access to the ventricles
Patient´s informed consent

Exclusion criteria

Known unevenness of the skull at the entry point
Slit ventricles; Frontal and occipital horn width ratio (FOHWR) < 0.05
Participation in another clinical trial with interfering endpoints

Treatment and study plan

Thomale-Guide

Device

Ventricular catheter placement with the Thomale-Guide instrument

Free-hand

Other

Ventricular catheter placement without a guidance (free-hand)

Primary outcomes

Rate of he primary successful ventricular catheter placement with a Grade I or Grade I b and location in the ipsilateral ventricle

Time frame: Within the first 40 days

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

Randomized Controlled Multi-center Trial Comparing the Ventricular Catheter Location Between Instrument Guided and Freehand Placement.

Acronym: GAVCA

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Mar 14, 2013
Registry last updated: Jun 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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