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Summative Usability Study of CEREBO® - a Non Invasive Intracranial Hemorrhage Detector

Primary Purpose

Usability

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 Usability 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.
  • MBBS
  • Ayush
  • Nurse
  • Others

Subjects

  • Of all ages and gender, have understood the study and gave a written informed consent.

Exclusion Criteria:

Subjects

  • Cognitively impaired subjects unable to understand the study procedure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Subjects examined by the study participants using CEREBO®

    Arm Description

    CEREBO® - A non-invasive intracranial haemorrhage detector Scan Duration - 40 seconds per subject Frequency - Every operator will perform CEREBO® scan on at least 10 different subjects Adverse Effect: None

    Outcomes

    Primary Outcome Measures

    To assess the usability of CEREBO® to detect intracranial haemorrhage
    A questionnaire filled by the participants will be assessed by the study team to assess the ease of use, ease of learning and satisfaction

    Secondary Outcome Measures

    To assess the rapidity of CEREBO® to detect intracranial haemorrhage
    The time to perform the CEREBO® scan per subject will be determined

    Full Information

    First Posted
    April 15, 2022
    Last Updated
    April 21, 2022
    Sponsor
    Bioscan Research Pvt. Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05340127
    Brief Title
    Summative Usability Study of CEREBO® - a Non Invasive Intracranial Hemorrhage Detector
    Official Title
    Summative Usability Study of a Novel Device - CEREBO® for Non Invasive Detection of Intracranial Haemorrhage
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 20, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    January 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 is one of the most common reasons for visits to the Emergency Department. More than 90% of patients who have suffered from head trauma present with a mild traumatic brain injury. Most of these patients do not present any symptom at the time of diagnosis thus delaying the detection. CEREBO®, a non-invasive, portable, rapid, point-of-care intracranial haemorrhage detector can avoid delayed detection by decreasing the time from injury to the initial CT scan. The study aims at assessing the summative usability of the device by determining its ease of use, ease of learning and satisfaction among the medical health professionals. The participants will be trained before the study and will be assessed periodically. Each participant will use the device on at least 10 subjects.
    Detailed Description
    A prospective interventional study designed to assess the summative usability and rapidity of CEREBO® - a portable device to detect intracranial haemorrhage. 10 participants from a Primary Health Centre will be enrolled in this study. The participants will be trained by the study staff before the study. The participant will fill in a questionnaire periodically. At the end of the study, the statistical analysis will be performed on the recorded data to establish the ease of use, ease of learning and satisfaction.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Usability
    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 study participants using CEREBO®
    Arm Type
    Experimental
    Arm Description
    CEREBO® - A non-invasive intracranial haemorrhage detector Scan Duration - 40 seconds per subject Frequency - Every operator will perform CEREBO® scan on at least 10 different subjects Adverse Effect: None
    Intervention Type
    Device
    Intervention Name(s)
    CEREBO®
    Intervention Description
    Usability Study
    Primary Outcome Measure Information:
    Title
    To assess the usability of CEREBO® to detect intracranial haemorrhage
    Description
    A questionnaire filled by the participants will be assessed by the study team to assess the ease of use, ease of learning and satisfaction
    Time Frame
    2 week
    Secondary Outcome Measure Information:
    Title
    To assess the rapidity of CEREBO® to detect intracranial haemorrhage
    Description
    The time to perform the CEREBO® scan per subject will be determined
    Time Frame
    2 week

    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 Ayush Nurse Others Subjects Of all ages and gender, have understood the study and gave a written informed consent. Exclusion Criteria: Subjects Cognitively impaired subjects unable to understand the study procedure
    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.Kaushik Vitthlapara
    Organizational Affiliation
    PHC, India
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Summative Usability Study of CEREBO® - a Non Invasive Intracranial Hemorrhage Detector

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