A Clinical Study on Albert Wong Frame-based Stereotactic Biopsy System for Brain (AWF)
Primary Purpose
Intracranial CNS Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
AW frame
Sponsored by
About this trial
This is an interventional diagnostic trial for Intracranial CNS Disorder focused on measuring AW frame, biopsy, stereotactic, accuracy, safety
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
Sites / Locations
- Department of Neurosurgery, Sarawak General HospitalRecruiting
- Hospital Miri
- Department of Neurosurgery, Hospital Sibu
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AW frame
Arm Description
AW frame biopsy
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Time
the preparation, operation and total operating room time
Length of hospital stay
The preoperative, postoperative and total length of hospital stay
Full Information
NCT ID
NCT03751085
First Posted
November 16, 2018
Last Updated
November 20, 2018
Sponsor
Ministry of Health, Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT03751085
Brief Title
A Clinical Study on Albert Wong Frame-based Stereotactic Biopsy System for Brain
Acronym
AWF
Official Title
A Clinical Study on Albert Wong Frame-based Stereotactic Biopsy System for Brain
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 18, 2018 (Actual)
Primary Completion Date
July 17, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Malaysia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial CNS Disorder
Keywords
AW frame, biopsy, stereotactic, accuracy, safety
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AW frame
Arm Type
Experimental
Arm Description
AW frame biopsy
Intervention Type
Device
Intervention Name(s)
AW frame
Intervention Description
AW stereotactic frame for intracranial lesion biopsy
Primary Outcome Measure Information:
Title
Diagnostic yield
Description
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.
Time Frame
For each patient 2 week after the biopsy
Title
Number of participants presenting with post-biopsy complications
Description
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.
Time Frame
an average of 2 week
Secondary Outcome Measure Information:
Title
Time
Description
the preparation, operation and total operating room time
Time Frame
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.
Title
Length of hospital stay
Description
The preoperative, postoperative and total length of hospital stay
Time Frame
an average of 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bik Liang Lau, MD
Phone
+60128822977
Email
laubikliang@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Albert Sii Hieng Wong, FRACS
Phone
+60128899863
Email
wonghm96@yahoo.com
Facility Information:
Facility Name
Department of Neurosurgery, Sarawak General Hospital
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bik Liang Lau, MD
Phone
+60128822977
Email
laubikliang@gmail.com
First Name & Middle Initial & Last Name & Degree
Albert Sii Hieng Wong, FRACS
Phone
+60128899863
Email
wonghm96@yahoo.com
Facility Name
Hospital Miri
City
Miri
State/Province
Sarawak
ZIP/Postal Code
98000
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bik Liang Lau, MD
Phone
+60128822977
Email
laubikliang@gmail.com
First Name & Middle Initial & Last Name & Degree
Albert Sii Hieng Wong, FRACS
Phone
+60128899863
Email
wonghm96@yahoo.com
Facility Name
Department of Neurosurgery, Hospital Sibu
City
Sibu
State/Province
Sarawak
ZIP/Postal Code
96000
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bik Liang Lau, MD
Phone
+60128822977
Email
laubikliang@gmail.com
First Name & Middle Initial & Last Name & Degree
Albert Sii Hieng Wong, FRACS
Phone
+60128899863
Email
wonghm96@yahoo.com
First Name & Middle Initial & Last Name & Degree
Adrian Wei Chih Ng, Master Neurosurgery
12. IPD Sharing Statement
Plan to Share IPD
No
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A Clinical Study on Albert Wong Frame-based Stereotactic Biopsy System for Brain
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