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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
Bioscan Research Pvt. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

  1. MBBS with Specialisation
  2. MBBS
  3. Nursing Staff
  4. Others

Subjects -

  1. Subjects with suspected traumatic brain injury and GCS > 13
  2. Of all ages and gender, have understood the study and gave a written informed consent.

Exclusion Criteria:

Subjects -

  1. Subjects with active bleeding or scalp laceration
  2. 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

    First Posted
    April 15, 2022
    Last Updated
    April 15, 2022
    Sponsor
    Bioscan Research Pvt. Ltd.
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    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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