Guided Application of Ventricular Catheters

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Brief Title

Guided Application of Ventricular Catheters

Official Title

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

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.
    


Study Type

Interventional


Primary Outcome

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


Condition

Hydrocephalus

Intervention

Thomale-Guide

Study Arms / Comparison Groups

 Thomale-Guide
Description:  Positioning of ventricular catheter with the Thomale-Guide instrument

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

144

Start Date

May 2013

Completion Date

January 2015

Primary Completion Date

January 2015

Eligibility Criteria

        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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Ulrich W Thomale, PD Dr. med., , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT01811589

Organization ID

AAG-G-H1221


Responsible Party

Sponsor

Study Sponsor

Aesculap AG


Study Sponsor

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


Verification Date

June 2019