NCT01811589

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 14, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

June 6, 2019

Status Verified

June 1, 2019

Enrollment Period

1.7 years

First QC Date

March 13, 2013

Last Update Submit

June 4, 2019

Conditions

Hydrocephalus

Keywords

ventricular catheter, hydrocephalus, shunt, brain disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Thomale-Guide

EXPERIMENTAL

Positioning of ventricular catheter with the Thomale-Guide instrument

Device: Thomale-Guide

Free-hand

OTHER

Ventricular catheter placement without a guidance (free-hand)

Other: Free-hand

Interventions

Thomale-GuideDEVICE

Ventricular catheter placement with the Thomale-Guide instrument

Thomale-Guide
Free-handOTHER

Ventricular catheter placement without a guidance (free-hand)

Free-hand

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Charité University Hospital, Division of Pediatric Neurosurgery

Berlin, 13353, Germany

Location

Trauma Hospital Berlin, Clinic for Neurosurgery

Berlin, Germany

Location

University Hospital Düsseldorf, Clinic for Neurosurgery

Düsseldorf, Germany

Location

Univeristätsmedizin Göttingen, Neurochirurgie

Göttingen, 37075, Germany

Location

Medizinische Hochschule Hannover, Neurochirurgie

Hanover, 30625, Germany

Location

Heidelberg University Hospital, Department of Neurosurgery

Heidelberg, Germany

Location

Klinikum Kassel GmbH / Department of Neurosurgery

Kassel, Germany

Location

Dietrich-Bonhoeffer-Klinikum / Department of Neurosurgery

Neubrandenburg, Germany

Location

University Hospital Tübingen, Department of Neurosurgery

Tübingen, Germany

Location

Related Publications (3)

  • 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.

    PMID: 23089936BACKGROUND

  • Thomale UW, Schaumann A, Stockhammer F, Giese H, Schuster D, Kastner S, Ahmadi AS, Polemikos M, Bock HC, Golz L, Lemcke J, Hermann E, Schuhmann MU, Beez T, Fritsch M, Orakcioglu B, Vajkoczy P, Rohde V, Bohner G. GAVCA Study: Randomized, Multicenter Trial to Evaluate the Quality of Ventricular Catheter Placement with a Mobile Health Assisted Guidance Technique. Neurosurgery. 2018 Aug 1;83(2):252-262. doi: 10.1093/neuros/nyx420.

    PMID: 28973670RESULT

  • Schaumann A, Thomale UW. Guided Application of Ventricular Catheters (GAVCA)--multicentre study to compare the ventricular catheter position after use of a catheter guide versus freehand application: study protocol for a randomised trail. Trials. 2013 Dec 12;14:428. doi: 10.1186/1745-6215-14-428.

    PMID: 24330776DERIVED

MeSH Terms

Conditions

HydrocephalusBrain Diseases

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Study Officials

  • Ulrich W Thomale, PD Dr. med.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2013

First Posted

March 14, 2013

Study Start

May 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

June 6, 2019

Record last verified: 2019-06

Locations

DE(9)