| CTRI Number |
CTRI/2022/04/041634 [Registered on: 04/04/2022] Trial Registered Prospectively |
| Last Modified On: |
01/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to assess the diagnostic performance of CEREBO® in detecting intracranial hematoma non-invasively. |
|
Scientific Title of Study
|
Assessment of Accuracy, Precision, and Feasibility of CEREBO® - a Near
Infrared Light Device to detect and categorize the intracranial hematoma in patients
with suspected brain injury compared to head CT scan as the gold standard:A
prospective Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EC/Approval/28/2022/07/03/2022 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jaimin Shah |
| Designation |
Associate Professor |
| Affiliation |
Civil Hospital, Ahmedabad |
| Address |
Department of Neurosurgery,
Division - Neurosurgery,
Room No. E6
Asarwa
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825576967 |
| Fax |
|
| Email |
jaimin_11@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaimin Shah |
| Designation |
Associate Professor |
| Affiliation |
Civil Hospital, Ahmedabad |
| Address |
Department of Neurosurgery,
Division - Neurosurgery,
Room No. E6
Asarwa
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825576967 |
| Fax |
|
| Email |
jaimin_11@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaimin Shah |
| Designation |
Associate Professor |
| Affiliation |
Civil Hospital, Ahmedabad |
| Address |
Department of Neurosurgery,
Division - Neurosurgery,
Room No. E6
Asarwa
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825576967 |
| Fax |
|
| Email |
jaimin_11@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Civil Hospital,
Neurosurgery Department,
Ahmedabad - Gujarat |
|
|
Primary Sponsor
|
| Name |
Dr Jaimin Shah |
| Address |
Civil Hospital,
Asarwa
Ahmedabad, Gujarat - 380016 |
| Type of Sponsor |
Other [Self] |
|
|
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 Jaimin Shah |
Civil Hospital, Ahmedabad |
Department of Neurosurgery,
Division - Neurosurgery
Room No. - E6
Ahmadabad
GUJARAT |
9825576967
jaimin_11@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Civil Hospital Ethics Committee |
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 |
Patients with a head injury referred for a CT scan within 72 hours from the onset of first symptoms of closed head injury |
|
| ExclusionCriteria |
| Details |
1. Patients with scalp bruises or scalp hematoma
2. History of neurosurgical procedure (e.g. decompressive craniectomy) with residual bone flap |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sensitivity of CEREBO®
Specificity of CEREBO®
Accuracy of CEREBO®
Positive and Negative Predictive Value of CEREBO®
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Categorisation of intracranial hematoma based on the bleed volume and depth of hematoma using CEREBO®
Perform the usability study |
1 year |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
11/04/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Traumatic Brain Injury (TBI) is the leading cause of death and disability across the globe. Time from injury to treatment is the most critical factor that determines the patient’s recovery. Mild TBI with no apparent symptoms are often left undiagnosed, thus delaying the treatment and hence recovery. This observational prospective study determines the efficacy of CEREBO® to detect the intracranial hematoma in comparison with the head CT scan. CEREBO® is a non-invasive, rapid, near-infrared based, point-of-care device. The study also aims to categorise the hematoma based on the bleed volume and depth. Early intracranial hemorrhage detection can help in the patient triaging thus increasing the chances of survival. |