Intracranial CNS Disorder Clinical Trial
Official title:
A Clinical Study on Albert Wong Frame-based Stereotactic Biopsy System for Brain
This study is to establish a new, alternative stereotactic biopsy frame (AW frame) in the field of stereotactic neurosurgery.
AW frame is a stereotactic biopsy frame created by Dr. Albert Sii Hieng Wong. A phantom study
had completed by Dr. Bik Liang Lau and Dr. Albert Sii Hieng Wong in year 2017 with good
accuracy. The phantom study result is going to be submitted for publication by early 2019.
With the good accuracy of AW frame in the phantom study, the frame has been approved by the
Medical Research & ethic committee (MREC) for human use in a research setting.
In the study, patient with intracranial lesion which required biopsy, whom fulfilled the
criteria will be recruited. All these patient will underwent standard biopsy procedure either
under local or general anaesthesia with AW frame mounted.
A localisation CT scanning will be perform with localiser fixed onto the head frame. Target
of the intracranial lesion is selected. The coordinates of the localizing points and the
selected target inserted into the AW stereo-calculator to generate the AW frame setting up
measurements.
Burr hole will be performed and biopsy taken by using Nashold® biopsy needle. An immediate
post-biopsy CT imaging will be performed to confirm the site of the biopsy. Patient will be
monitored in the neurosurgery ward for any complications.
Histopathologic analysis of the biopsies will be done using usual procedure.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03710278 -
The Effectiveness and Safety of Human Lumbar Puncture Assist Device (LPat)
|