| CTRI Number |
CTRI/2024/07/070704 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the Utility of CEREBO - A machine learning powered near-Infrared Spectroscopy based device, in reducing the mean transfer time from injury to treatment in patients with traumatic brain injury |
|
Scientific Title of Study
|
Comprehensive Assessment of CEREBO to evaluate its clinical performance, utility and Usability in
the Brain Injury Management |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Zahir Quazi |
| Designation |
Director (R&D) |
| Affiliation |
Datta Meghe Institute of Higher Education & Research |
| Address |
Department of Neurosurgery
Wardha
MAHARASHTRA
442004
India |
| Phone |
9765404065 |
| Fax |
|
| Email |
zahirquazi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zahir Quazi |
| Designation |
Director (R&D) |
| Affiliation |
Datta Meghe Institute of Higher Education & Research |
| Address |
Department of Neurosurgery
Wardha
MAHARASHTRA
442004
India |
| Phone |
9765404065 |
| Fax |
|
| Email |
zahirquazi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Zahir Quazi |
| Designation |
Director (R&D) |
| Affiliation |
Datta Meghe Institute of Higher Education & Research |
| Address |
Department of Neurosurgery
Wardha
MAHARASHTRA
442004
India |
| Phone |
9765404065 |
| Fax |
|
| Email |
zahirquazi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR)
V. Ramalingaswami Bhawan,
P.O. Box No. 4911.
Ansari Nagar,
New Delhi - 110029
India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Indian Council of Medical Research. V. Ramalingaswami Bhawan,
P.O. Box No. 4911. Ansari Nagar, New Delhi - 110029 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Bioscan Research Pvt Ltd |
Shivalik Corporate Park, D Mart 2, C/306/A,
Satellite, Ahmedabad, Gujarat 380015 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Zahir Quazi |
Datta Meghe Institute of Medical Sciences |
Department of Neurosurgery
Wardha
MAHARASHTRA |
9765404065
zahirquazi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education & Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S068||Other specified intracranial injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIR based device - CEREBO |
The experimental group will consist of head injury patients who are recommended for head CT/MRI scans. The participants will undergo a one-time scan with the CEREBO device prior to their standard care during triaging. Each lobe is scanned individually, with each scan taking approximately 5 seconds. |
| Comparator Agent |
Standard care of traetment |
The control group will comprise head injury patients who are also recommended for head CT/MRI scans but will not receive the CEREBO scan. The outcomes between these two groups will be compared, specifically focusing on any differences in the time taken to receive CT scans and subsequent treatment. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with head injury referred for head CT/MRI scan |
|
| ExclusionCriteria |
| Details |
Patients with scalp bruises or hematoma. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing the utility of CEREBO in reducing the mean transfer time from injury to treatment |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the usability among healthcare professionals & operators & identify areas of improvement for specific use cases |
3 years |
|
|
Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This clinical study aims to assess the effectiveness of the CEREBO device in decreasing the mean time from injury to treatment by comparing outcomes between a control group and an experimental group. In cases of traumatic brain injury (TBI), timely intervention is crucial. The study will specifically evaluate CEREBO’s impact on operational efficiency, focusing on its ability to reduce the mean time from the initial point of injury to the CT scan and thus the treatment. This analysis will help determine if the integration of CEREBO into standard care protocols can expedite treatment and potentially improve outcomes for TBI patients. |