Intracranial CNS Disorder Clinical Trial
— AWFOfficial title:
A Clinical Study on Albert Wong Frame-based Stereotactic Biopsy System for Brain
This study is to establish a new, alternative stereotactic biopsy frame (AW frame) in the field of stereotactic neurosurgery.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Ministry of Health, Malaysia |
Malaysia,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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