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

Intracranial CNS Disorder Clinical Trial

— AWF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03751085
• Other study ID #: NMRR-17-3247-36799
• Status: Recruiting
• Phase: N/A
• Start date: July 18, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2018
• Source: Ministry of Health, Malaysia
• Contact: Bik Liang Lau, MD
• Phone: +60128822977
• Email: laubikliang[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2020
• Est. primary completion date: July 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Intracranial CNS Disorder

Intervention

Device:
• AW frame
AW stereotactic frame for intracranial lesion biopsy

Locations

Country	Name	City	State
Malaysia	Department of Neurosurgery, Sarawak General Hospital	Kuching	Sarawak
Malaysia	Hospital Miri	Miri	Sarawak
Malaysia	Department of Neurosurgery, Hospital Sibu	Sibu	Sarawak

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic yield	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.	For each patient 2 week after the biopsy
Primary	Number of participants presenting with post-biopsy complications	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.	an average of 2 week
Secondary	Time	the preparation, operation and total operating room 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.
Secondary	Length of hospital stay	The preoperative, postoperative and total length of hospital stay	an average of 1 week