Summative Usability Study of CEREBO® - a Non Invasive Intracranial Hemorrhage Detector
Summative Usability Study of a Novel Device - CEREBO® for Non Invasive Detection of Intracranial Haemorrhage
1 other identifier
interventional
10
0 countries
N/A
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.
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
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2022
CompletedStudy Start
First participant enrolled
April 20, 2022
CompletedFirst Posted
Study publicly available on registry
April 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2023
CompletedApril 22, 2022
April 1, 2022
9 months
April 15, 2022
April 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
2 week
Secondary Outcomes (1)
To assess the rapidity of CEREBO® to detect intracranial haemorrhage
2 week
Study Arms (1)
Subjects examined by the study participants using CEREBO®
EXPERIMENTALCEREBO® - 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
Interventions
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
- Ayush
- Nurse
- Others
- Subjects
- Of all ages and gender, have understood the study and gave a written informed consent.
You may not qualify if:
- Subjects
- Cognitively impaired subjects unable to understand the study procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr.Kaushik Vitthlapara
PHC, 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 20, 2022
Primary Completion
December 31, 2022
Study Completion
January 31, 2023
Last Updated
April 22, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share