Clinical trial NCT03751085: A Clinical Study on Albert Wong Frame-based Stereotactic Biopsy System for Brain
Official title: A Clinical Study on Albert Wong Frame-based Stereotactic Biopsy System for Brain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intracranial CNS Disorder
Keywords: AW frame
biopsy
stereotactic
accuracy
safety
Lead sponsor: Ministry of Health, Malaysia
Sponsor class: OTHER_GOV
First posted: 2018-11-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic yield
timeFrame: For each patient 2 week after the biopsy
measure: Number of participants presenting with post-biopsy complications
timeFrame: an average of 2 week
Secondary outcomes:
measure: Time
timeFrame: From the time of the participant is transferred to the OR until the time of the participant transfer out of it, assessed on the day of operation.
measure: Length of hospital stay
timeFrame: an average of 1 week
Other outcomes:
Locations:
city: Kuching
country: Malaysia
facility: Department of Neurosurgery, Sarawak General Hospital
state: Sarawak
city: Miri
country: Malaysia
facility: Hospital Miri
state: Sarawak
city: Sibu
country: Malaysia
facility: Department of Neurosurgery, Hospital Sibu
state: Sarawak
Study officials:
References: