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

Sponsor

Ministry of Health, Malaysia (Other)

Overall Status

Unknown status

CT.gov ID

NCT03751085

Collaborator

(none)

Enrollment

Locations

Arm

29.5

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Intracranial CNS Disorder	Device: AW frame	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jul 18, 2018

Anticipated Primary Completion Date :

Jul 17, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AW frame AW frame biopsy	Device: AW frame AW stereotactic frame for intracranial lesion biopsy

Arm

Intervention/Treatment

Experimental: AW frame

AW frame biopsy

Device: AW frame

AW stereotactic frame for intracranial lesion biopsy

Outcome Measures

Primary Outcome Measures

Diagnostic yield [For each patient 2 week after the biopsy]
The diagnostic yield is defined as the number of patients in whom the histopathological diagnosis was made based of the biological material obtained during the biopsy.
Number of participants presenting with post-biopsy complications [an average of 2 week]
The presence of acute postoperative complication is noted if any of following findings is present: wound site infection up to two weeks after the biopsy, a new neurological deficit developed up to 24 hours following the operation and present in a follow up clinical examination 2 weeks postoperatively, intraparenchymal hematoma with radiological evidence.

Secondary Outcome Measures

Time [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.]
the preparation, operation and total operating room time
Length of hospital stay [an average of 1 week]
The preoperative, postoperative and total length of hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurosurgery, Sarawak General Hospital	Kuching	Sarawak	Malaysia	93586
2	Hospital Miri	Miri	Sarawak	Malaysia	98000
3	Department of Neurosurgery, Hospital Sibu	Sibu	Sarawak	Malaysia	96000