Guided Application of Ventricular Catheters

Hydrocephalus Clinical Trial

— GAVCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01811589
• Other study ID #: AAG-G-H1221
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: January 2015

Study information

• Verified date: June 2019
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hydrocephalus

Intervention

Device:
• Thomale-Guide
Ventricular catheter placement with the Thomale-Guide instrument

Other:
• Free-hand
Ventricular catheter placement without a guidance (free-hand)

Locations

Country	Name	City	State
Germany	Charité University Hospital, Division of Pediatric Neurosurgery	Berlin
Germany	Trauma Hospital Berlin, Clinic for Neurosurgery	Berlin
Germany	University Hospital Düsseldorf, Clinic for Neurosurgery	Düsseldorf
Germany	Univeristätsmedizin Göttingen, Neurochirurgie	Göttingen
Germany	Medizinische Hochschule Hannover, Neurochirurgie	Hannover
Germany	Heidelberg University Hospital, Department of Neurosurgery	Heidelberg
Germany	Klinikum Kassel GmbH / Department of Neurosurgery	Kassel
Germany	Dietrich-Bonhoeffer-Klinikum / Department of Neurosurgery	Neubrandenburg
Germany	University Hospital Tübingen, Department of Neurosurgery	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Thomale UW, Knitter T, Schaumann A, Ahmadi SA, Ziegler P, Schulz M, Miethke C. Smartphone-assisted guide for the placement of ventricular catheters. Childs Nerv Syst. 2013 Jan;29(1):131-9. doi: 10.1007/s00381-012-1943-1. Epub 2012 Oct 23. — View Citation

Thomale UW, Schaumann A, Stockhammer F, Giese H, Schuster D, Kästner S, Ahmadi AS, Polemikos M, Bock HC, Gölz L, Lemcke J, Hermann E, Schuhmann MU, Beez T, Fritsch M, Orakcioglu B, Vajkoczy P, Rohde V, Bohner G. GAVCA Study: Randomized, Multicenter Trial — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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