Guided Application of Ventricular Catheters

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01811589

Acronym

GAVCA

Enrollment

144

Registered

2013-03-14

Start date

2013-05-31

Completion date

2015-01-31

Last updated

2019-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydrocephalus

Keywords

ventricular catheter, hydrocephalus, shunt, brain disease

Brief summary

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.

Detailed description

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.

Interventions

DEVICEThomale-Guide

Ventricular catheter placement with the Thomale-Guide instrument

OTHERFree-hand

Ventricular catheter placement without a guidance (free-hand)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Rate of he primary successful ventricular catheter placement with a Grade I or Grade I b and location in the ipsilateral ventricle	Within the first 40 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026