Usability Study of CEREBO® - A Novel Non-invasive Intracranial Bleed Detector
Summative Usability Study of CEREBO® in Traumatic Brain Injury Patients to Determine Ease of Use, Ease of Learning and Satisfaction
2 other identifiers
interventional
10
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2022
CompletedFirst Posted
Study publicly available on registry
April 21, 2022
CompletedStudy Start
First participant enrolled
April 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedApril 21, 2022
April 1, 2022
1 year
April 15, 2022
April 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the summative usability of CEREBO®
Assessment of ease of use, ease of learning and satisfaction through the questionnaires filled by the operators.
1 year
Study Arms (1)
Subjects examined by the operations with CEREBO®
EXPERIMENTALCEREBO® - 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
Interventions
Near-infrared based point-of-care portable intracranial hematoma detector
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Subjects -
- Subjects with active bleeding or scalp laceration
- Subjects with large extracranial lesions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Jaimin Shah
Civil Hospital India
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2022
First Posted
April 21, 2022
Study Start
April 25, 2022
Primary Completion
April 30, 2023
Study Completion
May 31, 2023
Last Updated
April 21, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share