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

November 20, 2018 updated by: Lau Bik Liang, Ministry of Health, Malaysia
This study is to establish a new, alternative stereotactic biopsy frame (AW frame) in the field of stereotactic neurosurgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Malaysia
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Recruiting
        • Department of Neurosurgery, Sarawak General Hospital
        • Contact:
        • Contact:
      • Miri, Sarawak, Malaysia, 98000
        • Not yet recruiting
        • Hospital Miri
        • Contact:
        • Contact:
      • Sibu, Sarawak, Malaysia, 96000
        • Not yet recruiting
        • Department of Neurosurgery, Hospital Sibu
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adrian Wei Chih Ng, Master Neurosurgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic yield
Time Frame: 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.
For each patient 2 week after the biopsy
Number of participants presenting with post-biopsy complications
Time Frame: 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.
an average of 2 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
Length of hospital stay
Time Frame: an average of 1 week
The preoperative, postoperative and total length of hospital stay
an average of 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Health, Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2018

Primary Completion (Anticipated)

July 17, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

November 16, 2018

First Submitted That Met QC Criteria

November 20, 2018

First Posted (Actual)

November 23, 2018

Study Record Updates

Last Update Posted (Actual)

November 23, 2018

Last Update Submitted That Met QC Criteria

November 20, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRR-17-3247-36799

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intracranial CNS Disorder

Clinical Trials on AW frame

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe