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

Ministry of Health, Malaysia

Status: Unknown

Conditions: Intracranial CNS Disorder

Treatments: Device: AW frame

Study type: Interventional

Funder types: Other

Identifiers

NCT03751085

NMRR-17-3247-36799

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >17 years old
• Radiological diagnosis of intracranial space occupying lesion of any etiology

Exclusion criteria

• Patient involved in other study trial
• Any serious medical condition that according to the investigator could interfere with the conduct of the study
• Unwillingness or inability to comply with study requirements

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

AW frame

Experimental group

Description:

AW frame biopsy

Treatment:

Device: AW frame