| CTRI Number |
CTRI/2024/07/071021 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the clinical effectiveness of CEREBO in traumatic brain injury management |
|
Scientific Title of Study
|
Investigating the Clinical Efficacy of CEREBO for early detection of Traumatic Brain Injury |
| 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 Vedang Mahajan |
| Designation |
Senior Resident, Department of Neurosurgery |
| Affiliation |
All India Institute of Medical Sciences, Delhi |
| Address |
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9130556880 |
| Fax |
|
| Email |
vedang.bp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharad S Kale |
| Designation |
Head of Department, Neurosurgery |
| Affiliation |
All India Institute of Medical Sciences, Delhi |
| Address |
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East
New Delhi
DELHI
110029
India |
| Phone |
9811426806 |
| Fax |
|
| Email |
skale67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vedang Mahajan |
| Designation |
Senior Resident, Department of Neurosurgery |
| Affiliation |
All India Institute of Medical Sciences, Delhi |
| Address |
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9130556880 |
| Fax |
|
| Email |
vedang.bp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research
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 Vedang Mahajan |
All India Institute Of Medical Sciences Delhi |
Department - Neurosurgery,
7th Floor, CNC Center
New Delhi
DELHI |
9130556880
vedang.bp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research All India Institute of Medical Sciences |
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 |
CEREBO |
Participants in the experimental group will undergo a one-time scan with the CEREBO device prior to receiving their standard care during triaging. The scanning process is brief, with each lobe being scanned in just 5 seconds. |
| Comparator Agent |
Control Group - Participants with the standard of care |
The participants in the control group will not receive the CEREBO scan. They will follow their standard of care during triaging. The two groups will be compared and analysed to compare the time to diagnosis and influence on treatment decisions |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Traumatic brain injury patients arriving at the emergency department and referred for a head CT scan |
|
| ExclusionCriteria |
| Details |
History of neurosurgical procedure (e.g. decompressive craniectomy) with residual bone flap |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the triaging efficacy of CEREBO® by calculating the
1. Sensitivity
2. Specificity
3. Accuracy
4. Positive Predictive Value
5. Negative Predictive Value |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the utility of CEREBO® in reducing the mean transfer time from triage to treatment |
3 years |
| To assess the usability of CEREBO® among healthcare professionals through survey questionnaires |
3 years |
|
|
Target Sample Size
|
Total Sample Size="198"
Sample Size from India="198"
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)
|
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
|
The primary purpose of this study is to rigorously evaluate the clinical efficacy of CEREBO, a non-invasive intracranial injury detection device, in identifying traumatic brain injuries (TBI). This encompasses assessing the device’s accuracy in determining the presence or absence of intracranial injuries in TBI patients. Additionally, the study aims to quantify the potential impact of CEREBO on operational efficiencies within clinical settings, specifically by measuring and comparing the experimental group (using CEREBO) and the control group (standard care) to establish CEREBO®’s efficacy in patient triage by quantifying the incidence of over-triage and under-triage. This will help determine if the introduction of CEREBO can significantly reduce the time taken for TBI patients to receive crucial diagnostic imaging. Lastly, the study seeks to thoroughly evaluate the usability of the CEREBO device, focusing on aspects such as the ease of use, time efficiency of scans, and the learning curve associated with its operation, to ensure its practical applicability in diverse healthcare environments.
|