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Guided Application of Ventricular Catheters (GAVCA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01811589
Recruitment Status : Completed
First Posted : March 14, 2013
Last Update Posted : June 6, 2019
Information provided by (Responsible Party):
Aesculap AG

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.

Condition or disease Intervention/treatment Phase
Hydrocephalus Device: Thomale-Guide Other: Free-hand Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Multi-center Trial Comparing the Ventricular Catheter Location Between Instrument Guided and Freehand Placement.
Study Start Date : May 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus

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

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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01811589

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Charité University Hospital, Division of Pediatric Neurosurgery
Berlin, Germany, 13353
Trauma Hospital Berlin, Clinic for Neurosurgery
Berlin, Germany
University Hospital Düsseldorf, Clinic for Neurosurgery
Düsseldorf, Germany
Univeristätsmedizin Göttingen, Neurochirurgie
Göttingen, Germany, 37075
Medizinische Hochschule Hannover, Neurochirurgie
Hannover, Germany, 30625
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, Germany
Sponsors and Collaborators
Aesculap AG
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Principal Investigator: Ulrich W Thomale, PD Dr. med. Charite University, Berlin, Germany
Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Aesculap AG Identifier: NCT01811589    
Other Study ID Numbers: AAG-G-H1221
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Keywords provided by Aesculap AG:
ventricular catheter, hydrocephalus, shunt, brain disease
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases