| CTRI Number |
CTRI/2024/07/070978 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess the clinical performance of CEREBO in detecting intracranial injuries in Brain Injury Patients |
|
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 |
| BR/CV/2024/004; Protocol Version: 1.0; Date: 24-04-2024 |
Protocol Number |
|
|
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, DMIMS
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, DMIMS
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, DMIMS
Wardha
MAHARASHTRA
442004
India |
| Phone |
9765404065 |
| Fax |
|
| Email |
zahirquazi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR) |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research (ICMR) |
| 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 |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients with a suspected head injury and 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 |
| Sensitivity, Specificity, Accuracy and other clinical parameters of CEREBO in detecting intracranial injury in TBI |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the number of referrals of TBI patients from peripheral hospitals that could have been prevented |
3 years |
| To assess the usability of CEREBO® among healthcare professionals through survey questionnaires. |
3 years |
|
|
Target Sample Size
|
Total Sample Size="119"
Sample Size from India="119"
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
|
N/A |
|
Date of First Enrollment (India)
|
29/07/2024 |
| 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 study will evaluate two key aspects of CEREBO. Firstly, the study will rigorously evaluate the clinical performance of CEREBO in accurately detecting the intracranial injuries, by comparing its diagnostic outcomes with those obtained from standard imaging techniques such as CT scans. Secondly, it will assess CEREBO’s impact on operational efficiency by measuring its ability to reduce the number of referrals from peripheral hospitals to the study site by identifying patients with no intracranial injury but were referred for head CT/MRI scans. Through these dual objectives, the trial aims to provide comprehensive insights into both the operational and clinical benefits of implementing CEREBO in the management of brain injuries, with the ultimate goal of improving patient outcomes and streamlining emergency care protocols.
|