| CTRI Number |
CTRI/2024/07/071639 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate the clinical performance of CEREBO in detecting intracranial injury in patients with traumatic brain injury |
|
Scientific Title of Study
|
Role of Non invasive Modalities in detecting intracranial haemorrhage and its radiological correlation |
| 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 Hansa Rot |
| Designation |
Resident, Neurosurgery |
| Affiliation |
Wockhardt Hospitals, Rajkot |
| Address |
Department - Neurosurgery, Ground Floor
Division - Trauma Center
Rajkot
GUJARAT
360007
India |
| Phone |
8320233067 |
| Fax |
|
| Email |
hansarot15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Viral Vasani |
| Designation |
Consultant, Neurosurgery |
| Affiliation |
Wockhardt Hospitals, Rajkot |
| Address |
Department - Neurosurgery, Ground Floor
Division - Trauma Center
Rajkot
GUJARAT
360007
India |
| Phone |
9742353191 |
| Fax |
|
| Email |
vmvasani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Viral Vasani |
| Designation |
Consultant, Neurosurgery |
| Affiliation |
Wockhardt Hospitals, Rajkot |
| Address |
Department - Neurosurgery, Ground Floor
Division - Trauma Center
GUJARAT
360007
India |
| Phone |
9742353191 |
| Fax |
|
| Email |
vmvasani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bioscan Research Pvt. Ltd.
Shivalik Corporate Park, D Mart 2, C/306/A, Satellite, Ahmedabad, Gujarat 380015
India |
|
|
Primary Sponsor
|
| Name |
Bioscan Research Pvt. Ltd. |
| Address |
Shivalik Corporate Park, D Mart 2, C/306/A, Satellite, Ahmedabad, Gujarat 380015
India |
| Type of Sponsor |
Other [Research Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hansa Rot |
N.M Virani Wockhardt hospital |
Department - Neurosurgery, Ground Floor
Division - Trauma Center
Rajkot
GUJARAT |
8320233067
hansarot15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| N M Virani Wockhardt Hospital |
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 |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with suspected TBI referred for head CT/MRI scan |
|
| ExclusionCriteria |
| Details |
Patients with scalp bruises and hematoma |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensitivity, Specificity, Accuracy and other parameters of CEREBO in determining presence or absence of an intracranial bleed |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the number of referrals that CEREBO could have prevented from other sites to the study site
2. To assess the usability of CEREBO® among healthcare professionals through survey questionnaires |
3 years |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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)
|
12/08/2024 |
| 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 will evaluate the efficacy of the non-invasive device, CEREBO, in detecting intracranial hemorrhage in patients with traumatic brain injury. The performance of CEREBO will be benchmarked against the gold standard, CT scans. This research aims to demonstrate CEREBO’s capability to identify intracranial hemorrhage at a presymptomatic stage, thereby enabling earlier detection and facilitating prompt intervention. Furthermore, the study will assess the potential reduction in unnecessary CT scans and associated radiation exposure, with a particular focus on vulnerable populations such as infants and pregnant women. |