A Clinical Study on Albert Wong Frame-based Stereotactic Biopsy System for Brain
AWF
1 other identifier
interventional
15
1 country
3
Brief Summary
This study is to establish a new, alternative stereotactic biopsy frame (AW frame) in the field of stereotactic neurosurgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2018
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 18, 2018
CompletedFirst Submitted
Initial submission to the registry
November 16, 2018
CompletedFirst Posted
Study publicly available on registry
November 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedNovember 23, 2018
November 1, 2018
2 years
November 16, 2018
November 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (2)
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
an average of 1 week
Study Arms (1)
AW frame
EXPERIMENTALAW frame biopsy
Interventions
Eligibility Criteria
You may qualify if:
- Age \>17 years old
- Radiological diagnosis of intracranial space occupying lesion of any etiology
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Department of Neurosurgery, Sarawak General Hospital
Kuching, Sarawak, 93586, Malaysia
Hospital Miri
Miri, Sarawak, 98000, Malaysia
Department of Neurosurgery, Hospital Sibu
Sibu, Sarawak, 96000, Malaysia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
November 16, 2018
First Posted
November 23, 2018
Study Start
July 18, 2018
Primary Completion
July 17, 2020
Study Completion
December 31, 2020
Last Updated
November 23, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share