Traumatic Brain InjuryNCT05340114
Usability Study of CEREBO® - A Novel Non-invasive Intracranial Bleed Detector
A study testing CEREBO® in people with Traumatic Brain Injury and Intracranial Hemorrhages, run by Bioscan Research Pvt. Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Intracranial Hemorrhages
- What is being tested?
- CEREBO®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- Subjects -
- Subjects with active bleeding or scalp laceration
- Subjects with large extracranial lesions
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Summative Usability Study of CEREBO® in Traumatic Brain Injury Patients to Determine Ease of Use, Ease of Learning and Satisfaction
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.
Read the 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®.
- Conditions
- Traumatic Brain Injury, Intracranial Hemorrhages
- Being tested
- CEREBO®
- Keywords
- Ease of Use, Ease of Learning, Satisfaction
- Medical subject headings
- Brain Injuries, Traumatic, Intracranial Hemorrhages, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEREBO®Device
Near-infrared based point-of-care portable intracranial hematoma detector
| Study group | Role | What they receive |
|---|---|---|
| Subjects examined by the operations with CEREBO® | Experimental | 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 Receives: Device: CEREBO® |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the summative usability of CEREBO®
Assessment of ease of use, ease of learning and satisfaction through the questionnaires filled by the operators.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start25 Apr 2022 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioscan Research Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Jaimin Shah, Principal investigator, Civil Hospital India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340114
- Sponsor's protocol ID
- BR/CV/2021/001
- Other IDs
- CTRI/2022/04/041634
- Status last verified
- Apr 2022
- First submitted
- 15 Apr 2022
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Summative Usability Study of CEREBO® in Traumatic Brain Injury Patients to Determine Ease of Use, Ease of Learning and Satisfaction
- ClinicalTrials.gov ID
- NCT05340114
- Acronym / sponsor ID
- BR/CV/2021/001
- Conditions
- Traumatic Brain Injury, Intracranial Hemorrhages
- Keywords
- Ease of Use, Ease of Learning, Satisfaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Bioscan Research Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2022 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects examined by the operations with CEREBO® | Experimental | Device: CEREBO®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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- Subjects -
- Subjects with active bleeding or scalp laceration
- Subjects with large extracranial lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CEREBO®Near-infrared based point-of-care portable intracranial hematoma detector | Device | Subjects examined by the operations with CEREBO® |
Primary outcome
To evaluate the summative usability of CEREBO®
Time frame: 1 year
Assessment of ease of use, ease of learning and satisfaction through the questionnaires filled by the operators.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Jaimin Shah principal investigator
Civil Hospital India
Questions about this trial
What is this clinical trial studying?
A study testing CEREBO® in people with Traumatic Brain Injury and Intracranial Hemorrhages, run by Bioscan Research Pvt. Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bioscan Research (7948994429 ext. 91, info@bioscanresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the summative usability of CEREBO® (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.