Guided Application of Ventricular Catheters (GAVCA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Aesculap AG
Sponsor:
Information provided by (Responsible Party):
Aesculap AG
ClinicalTrials.gov Identifier:
NCT01811589
First received: March 13, 2013
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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 Intervention
Hydrocephalus
Device: Thomale-Guide
Other: Free-hand

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Multi-center Trial Comparing the Ventricular Catheter Location Between Instrument Guided and Freehand Placement.

Resource links provided by NLM:


Further study details as provided by Aesculap AG:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 144
Study Start Date: May 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thomale-Guide
Positioning of ventricular catheter with the Thomale-Guide instrument
Device: Thomale-Guide
Ventricular catheter placement with the Thomale-Guide instrument
Free-hand
Ventricular catheter placement without a guidance (free-hand)
Other: Free-hand
Ventricular catheter placement without a guidance (free-hand)

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01811589

Contacts
Contact: Magdalena Motyl, Dr. +49-7461-95-31482 magdalena.motyl@aesculap.de

Locations
Germany
Charité University Hospital, Division of Pediatric Neurosurgery Recruiting
Berlin, Germany, 13353
Trauma Hospital Berlin, Clinic for Neurosurgery Completed
Berlin, Germany
University Hospital Düsseldorf, Clinic for Neurosurgery Recruiting
Düsseldorf, Germany
Univeristätsmedizin Göttingen, Neurochirurgie Recruiting
Göttingen, Germany, 37075
Medizinische Hochschule Hannover, Neurochirurgie Not yet recruiting
Hannover, Germany, 30625
Heidelberg University Hospital, Department of Neurosurgery Recruiting
Heidelberg, Germany
Klinikum Kassel GmbH / Department of Neurosurgery Recruiting
Kassel, Germany
Dietrich-Bonhoeffer-Klinikum / Department of Neurosurgery Recruiting
Neubrandenburg, Germany
University Hospital Tübingen, Department of Neurosurgery Recruiting
Tübingen, Germany
Sponsors and Collaborators
Aesculap AG
Investigators
Principal Investigator: Ulrich W Thomale, PD Dr. med. Charite University, Berlin, Germany
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Aesculap AG
ClinicalTrials.gov Identifier: NCT01811589     History of Changes
Other Study ID Numbers: AAG-G-H1221
Study First Received: March 13, 2013
Last Updated: June 23, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Aesculap AG:
ventricular catheter, hydrocephalus, shunt, brain disease

Additional relevant MeSH terms:
Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Hypertension

ClinicalTrials.gov processed this record on July 24, 2014