Evaluation of Clinical Decision Support System for Intracranial Hemorrhage Using Brain CT Images

NCT04983953 | Completed

• 1 other identifier: HR-cHS-01
• Study Type: observational
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

cHS is a software that has been pre-learned based on a intracranial haemorrhage diagnosis model using brain CT images, and clinical decision support system for diagnosing intracranial haemorrhage by automatically analyzing brain CT images by assisting the medical team. The specific aims of this study are to evaluate efficacy of cHS for intracranial haemorrhage compared to the sensitivity and specificity levels of predicate device which is currently approved to triage intracranial haemorrhage.

Conditions

Intracranial Hemorrhages

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of cHS

  Sensitivity and specificity of cHS in diagnosis of intracranial haemorrhage based on golden standards

  Within 4 weeks after collecting data

Study Arms (2)

Abnormal

A patient diagnosed with intracranial haemorrhage after a brain CT scan

Device: cHS

Normal

A normal person or a patient not diagnosed with intracranial haemorrhage after a brain CT scan

Device: cHS

Interventions

cHS DEVICE

Clinical decision support system for diagnosing intracranial haemorrhage

Abnormal; Normal

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

(1) Adults over 19 years old (2) Brain CT images acquired (3) who confirmed with intracranial haemorrhage(abnormal cohort) or not intracranial haemorrhage or normal(normal cohort)

You may qualify if:

• Adults over 19 years old
• Brain CT acquired
• Abnormal cohort: A patient diagnosed with intracranial haemorrhage after a brain CT scan
• Normal cohort: A normal person or a patient not diagnosed with intracranial haemorrhage after a brain CT scan

You may not qualify if:

• Patients with brain tumor or cerebral toxoplasmosis
• Patients with brain abscess or brain calcification
• Poor or incomplete brain CT image quality

Sponsors & Collaborators

• Heuron Inc.: lead

Study Sites (1)

Gachon University Gil Medical Center

Incheon, Namdong-gu, 21565, South Korea

Location

MeSH Terms

Conditions

Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: July 30, 2021
• Study Start: June 23, 2021
• Primary Completion: July 28, 2021
• Study Completion: July 28, 2021
• Last Updated: January 14, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)