Guided Application of Ventricular Catheters (GAVCA)

June 4, 2019 updated by: Aesculap AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Charité University Hospital, Division of Pediatric Neurosurgery
      • Berlin, Germany
        • Trauma Hospital Berlin, Clinic for Neurosurgery
      • Düsseldorf, Germany
        • University Hospital Düsseldorf, Clinic for Neurosurgery
      • Göttingen, Germany, 37075
        • Univeristätsmedizin Göttingen, Neurochirurgie
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover, Neurochirurgie
      • Heidelberg, Germany
        • Heidelberg University Hospital, Department of Neurosurgery
      • Kassel, Germany
        • Klinikum Kassel GmbH / Department of Neurosurgery
      • Neubrandenburg, Germany
        • Dietrich-Bonhoeffer-Klinikum / Department of Neurosurgery
      • Tübingen, Germany
        • University Hospital Tübingen, Department of Neurosurgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thomale-Guide
Positioning of ventricular catheter with the Thomale-Guide instrument
Device: Thomale-Guide
Ventricular catheter placement with the Thomale-Guide instrument
Other: Free-hand
Ventricular catheter placement without a guidance (free-hand)
Other: Free-hand
Ventricular catheter placement without a guidance (free-hand)

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: Within the first 40 days
Within the first 40 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Investigators

  • Principal Investigator: Ulrich W Thomale, PD Dr. med., Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

March 13, 2013

First Submitted That Met QC Criteria

March 13, 2013

First Posted (Estimate)

March 14, 2013

Study Record Updates

Last Update Posted (Actual)

June 6, 2019

Last Update Submitted That Met QC Criteria

June 4, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-G-H1221

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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