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Clinical trial to evaluate the clinical effectiveness of pneumothorax reading results using artificial intelligence software in chest X-ray images

A retrospective, single-institution, single-group, confirmatory clinical trial to evaluate the clinical effectiveness of the results of pneumothorax reading using artificial intelligence-based grade 2 medical image detection/diagnosis software (CXR-01) in chest X-ray images exam

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008086
Enrollment
130
Registered
2023-01-06
Start date
2023-01-30
Completion date
Unknown
Last updated
2023-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Comparison of pneumothorax image segmentation results with software analysis results

Sponsors

Promedius
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: over the age of 19 130 patients who underwent chest X-ray examination within one day after the procedure between January 1, 2022 and June 20, 2022

Exclusion criteria

Exclusion criteria: Incomplete chest X-ray image Chest X-ray examination or follow-up is not performed for more than 1 day after treatment under the age of 19 or pregnant woman Difficulty in conducting clinical trials

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity

Secondary

MeasureTime frame
Dice Coefficient Score

Countries

Korea, Republic of

Contacts

Public ContactSangmin Lee

Asan Medical Center

sangmin.lee.md@gmail.com+82-2-3010-4382

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026