Usability Study of CEREBO® - A Novel Non-invasive Intracranial Bleed Detector
Primary Purpose
Traumatic Brain Injury, Intracranial Hemorrhages
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CEREBO®
Sponsored by
About this trial
This is an interventional device feasibility trial for Traumatic Brain Injury focused on measuring Ease of Use, Ease of Learning, Satisfaction
Eligibility Criteria
Inclusion Criteria:
Operators -
Medical health professionals >18 years of age with a valid medical license to practice medicine belonging to one of the following categories and have given a written consent to participate in the study.
- MBBS with Specialisation
- MBBS
- Nursing Staff
- Others
Subjects -
- Subjects with suspected traumatic brain injury and GCS > 13
- Of all ages and gender, have understood the study and gave a written informed consent.
Exclusion Criteria:
Subjects -
- Subjects with active bleeding or scalp laceration
- Subjects with large extracranial lesions
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects examined by the operations with CEREBO®
Arm Description
CEREBO® - A portable non-invasive device to detect intracranial haemorrhage Frequency - The operator will scan at least 10 patients Duration - 40 seconds per subject No adverse effect or contraindications
Outcomes
Primary Outcome Measures
To evaluate the summative usability of CEREBO®
Assessment of ease of use, ease of learning and satisfaction through the questionnaires filled by the operators.
Secondary Outcome Measures
Full Information
NCT ID
NCT05340114
First Posted
April 15, 2022
Last Updated
April 15, 2022
Sponsor
Bioscan Research Pvt. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05340114
Brief Title
Usability Study of CEREBO® - A Novel Non-invasive Intracranial Bleed Detector
Official Title
Summative Usability Study of CEREBO® in Traumatic Brain Injury Patients to Determine Ease of Use, Ease of Learning and Satisfaction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 25, 2022 (Anticipated)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioscan Research Pvt. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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. CEREBO® is a non-invasive, rapid, near-infrared based, point-of-care device that can detect an intracranial bleed at an early stage.
Detailed Description
This prospective study determines the usability of CEREBO® to detect the intracranial hematoma. The operators will receive a training session before the study and will be evaluated at the end of the study through a survey questionnaire for ease of use, ease of learning and satisfaction. Each operator will examine at least 10 subjects with CEREBO®.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Intracranial Hemorrhages
Keywords
Ease of Use, Ease of Learning, Satisfaction
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Subjects examined by the operations with CEREBO®
Arm Type
Experimental
Arm Description
CEREBO® - A portable non-invasive device to detect intracranial haemorrhage Frequency - The operator will scan at least 10 patients Duration - 40 seconds per subject No adverse effect or contraindications
Intervention Type
Device
Intervention Name(s)
CEREBO®
Intervention Description
Near-infrared based point-of-care portable intracranial hematoma detector
Primary Outcome Measure Information:
Title
To evaluate the summative usability of CEREBO®
Description
Assessment of ease of use, ease of learning and satisfaction through the questionnaires filled by the operators.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Operators -
Medical health professionals >18 years of age with a valid medical license to practice medicine belonging to one of the following categories and have given a written consent to participate in the study.
MBBS with Specialisation
MBBS
Nursing Staff
Others
Subjects -
Subjects with suspected traumatic brain injury and GCS > 13
Of all ages and gender, have understood the study and gave a written informed consent.
Exclusion Criteria:
Subjects -
Subjects with active bleeding or scalp laceration
Subjects with large extracranial lesions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bioscan Research
Phone
7948994429
Ext
91
Email
info@bioscanresearch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Jaimin Shah
Organizational Affiliation
Civil Hospital India
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Usability Study of CEREBO® - A Novel Non-invasive Intracranial Bleed Detector
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