NCT05572619

Brief Summary

cELVO is a software that has been pre-learned based on a large vessel occlusion diagnosis model using brain CT images, and clinical decision support system for diagnosing large vessel occlusion by automatically analyzing brain CT images by assisting the medical team. The specific aims of this study are to evaluate efficacy of cELVO compared to the sensitivity and specificity levels of medical team to diagnosis with and without cELVO used.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
479

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 22, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2022

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
Last Updated

October 7, 2022

Status Verified

October 1, 2022

Enrollment Period

6 months

First QC Date

October 4, 2022

Last Update Submit

October 5, 2022

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of medical team compared with/without cELVO

    Sensitivity and specificity of determining large vessel occlusion of medical team when using cELVO compared to not using cELVO

    Within 2 weeks after completion of reading

Secondary Outcomes (5)

  • Accuracy of medical team compared with/without cELVO

    Within 2 weeks after completion of reading

  • ROC Curve for medical team compared with/without cELVO

    Within 2 weeks after completion of reading

  • AUC values for medical team compared with/without cELVO

    Within 2 weeks after completion of reading

  • Sensitivity and specificity of each reader compared with/without cELVO

    Within 2 weeks after completion of reading

  • Sensitivity and specificity of cELVO

    Within 2 weeks after completion of reading

Study Arms (2)

Positive group

A patient diagnosed with large vessel occlusion after a non-contrast CT, CT perfusion and CT angiography

Device: 1st ReadingDevice: 2nd Reading

Negative group

A normal person or a patient not diagnosed with intracranial haemorrhage after a non-contrast CT, CT perfusion and CT angiography

Device: 1st ReadingDevice: 2nd Reading

Interventions

1st ReadingDEVICE

The medical team visually checks the non-contrast CT without cELVO and diagnose the large vessel occlusion.

Also known as: Stage 1
Negative groupPositive group
2nd ReadingDEVICE

The medical team visually checks the non-contrast CT with assistance from the cELVO and diagnose the large vessel occlusion.

Also known as: Stage 2
Negative groupPositive group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

(1) Adults over 19 years old (2) Brain non-contrast CT, CT perfusion and CT angiography acquired (3) who confirmed with large vessel occlusion(positive group) or not large vessel occlusion or normal(negative group)

You may qualify if:

  • Adults over 19 years old
  • Brain non-contrast CT, CT perfusion and CT angiography acquired
  • Positive group: A patient diagnosed with large vessel occlusion after a non-contrast CT, CT perfusion and CT angiography
  • Negative group: A normal person or a patient not diagnosed with large vessel occlusion after a non-contrast CT, CT perfusion and CT angiography

You may not qualify if:

  • Poor or incomplete brain non-contrast CT, CT perfusion and CT angiography quality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Medical Center

Incheon, Namdong-gu, 21565, South Korea

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Norwood ProceduresFontan Procedure

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical ProceduresHeart Bypass, RightAnastomosis, SurgicalVascular GraftingVascular Surgical Procedures

Study Officials

  • Myeong Jin Kim, M.D.pH.D

    Gachon University Gil Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
OTHER
Target Duration
14 Weeks
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2022

First Posted

October 7, 2022

Study Start

March 22, 2022

Primary Completion

September 8, 2022

Study Completion

September 8, 2022

Last Updated

October 7, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)