Status:
COMPLETED
Guided Application of Ventricular Catheters
Lead Sponsor:
Aesculap AG
Conditions:
Hydrocephalus
Eligibility:
All Genders
Phase:
NA
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 phon...
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 sh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT01811589
Start Date
May 1 2013
End Date
January 1 2015
Last Update
June 6 2019
Active Locations (9)
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1
Charité University Hospital, Division of Pediatric Neurosurgery
Berlin, Germany, 13353
2
Trauma Hospital Berlin, Clinic for Neurosurgery
Berlin, Germany
3
University Hospital Düsseldorf, Clinic for Neurosurgery
Düsseldorf, Germany
4
Univeristätsmedizin Göttingen, Neurochirurgie
Göttingen, Germany, 37075