| CTRI Number |
CTRI/2024/04/065582 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
11/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Feasibility Assessment of CEREBO - A machine learning powered near-Infrared Spectroscopy based device, in Traumatic Brain Injury: A Post Market Surveillance Study |
|
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 |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jaimin Shah |
| Designation |
Head of Department, Neurosurgery |
| Affiliation |
Civil Hospital, Ahmedabad |
| Address |
Department of Neurosurgery,
Division- Neurosurgery,
Room No: E6/Trauma ward
Asarwa
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825576967 |
| Fax |
|
| Email |
jaimin_11@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaimin Shah |
| Designation |
Head of Department, Neurosurgery |
| Affiliation |
Civil Hospital, Ahmedabad |
| Address |
Department of Neurosurgery,
Division- Neurosurgery,
Room No: E6/Trauma ward
Asarwa
GUJARAT
380016
India |
| Phone |
9825576967 |
| Fax |
|
| Email |
jaimin_11@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaimin Shah |
| Designation |
Head of Department, Neurosurgery |
| Affiliation |
Civil Hospital, Ahmedabad |
| Address |
Department of Neurosurgery,
Division- Neurosurgery,
Room No: E6/Trauma ward
Asarwa
GUJARAT
380016
India |
| Phone |
9825576967 |
| Fax |
|
| Email |
jaimin_11@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
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/Trauma Ward
Ahmadabad
GUJARAT |
9825576967
jaimin_11@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| B.J. Medical College & Civil Hospital, Ahmedabad |
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 |
A machine learning powered near infrared spectroscopy based device will be used to scan all patients with suspected TBI and referred for a head CT scan. |
| 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 scan |
|
| ExclusionCriteria |
| Details |
Patients with scalp bruises or 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 clinical parameters of CEREBO in detecting intracranial injury in TBI |
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="91"
Sample Size from India="91"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
23/04/2024 |
| 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 post-market surveillance study is designed to assess the diagnostic capabilities of CEREBOⓇ, a machine learning-enhanced near-infrared spectroscopy device, against the benchmark of CT scans in treating traumatic brain injury (TBI) patients. It will investigate CEREBOⓇ’s precision, sensitivity, specificity, and its overall effectiveness in identifying intracranial injuries among those suffering from TBI.The research will generate crucial insights on CEREBOⓇ’s performance and practicality in actual clinical environments, shedding light on its ability to enhance existing diagnostic approaches for TBI care. Through a direct comparison with CT scans, the recognized standard for diagnosing TBI, this study seeks to thoroughly evaluate CEREBOⓇ’s functionality and identify potential areas for enhancement, thereby promoting improved treatment outcomes for TBI patients.
|