A Clinical Study on Albert Wong Frame-based Stereotactic Biopsy System for Brain

Last updated: November 20, 2018
Sponsor: Ministry of Health, Malaysia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT03751085
NMRR-17-3247-36799
  • Ages > 18
  • All Genders

Study Summary

This study is to establish a new, alternative stereotactic biopsy frame (AW frame) in the field of stereotactic neurosurgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >17 years old

  • Radiological diagnosis of intracranial space occupying lesion of any etiology

Exclusion

Exclusion Criteria:

  • Patient involved in other study trial

  • Any serious medical condition that according to the investigator could interfere withthe conduct of the study

  • Unwillingness or inability to comply with study requirements

Study Design

Total Participants: 15
Study Start date:
July 18, 2018
Estimated Completion Date:
December 31, 2020

Study Description

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.

Connect with a study center

  • Department of Neurosurgery, Sarawak General Hospital

    Kuching, Sarawak 93586
    Malaysia

    Active - Recruiting

  • Hospital Miri

    Miri, Sarawak 98000
    Malaysia

    Site Not Available

  • Department of Neurosurgery, Hospital Sibu

    Sibu, Sarawak 96000
    Malaysia

    Site Not Available

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