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A multicenter, prospective clinical performance study to evaluate the diagnostic efficacy of an AI-based microscope in assisting the detection of tumors in samples resected from early gastric cancer patients

A multicenter, blinded, prospective, single-group, confirmatory clinical performance study to evaluate the diagnostic efficacy (concordance with reference standards) of an AI-based miniature confocal fluorescence microscope in assisting the detection of tumors in fresh tissue samples resected from early gastric cancer patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0010557
Enrollment
77
Registered
2025-05-28
Start date
2025-06-02
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

None listed

Interventions

None listed

Sponsors

Vpix Medical
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Specimens from male and female patients over the age of 19 2) ESD treatment is scheduled to be performed due to suspected early gastric cancer, and specimens from patients with potential tumor resection 3) Samples obtained from patients who understand and sign the consent form

Exclusion criteria

Exclusion criteria: 1) If the necrosis of the lesion site (central part of the specimen) is severe and a histopathological examination (permanent section test) for the final diagnosis is needed quickly 2) The ESD specimen is within 2.5 cm or greater than 5 cm in diameter 3) Other organizations deemed unsuitable for clinical performance tests, such as having conditions that may affect the evaluation of clinical performance test results, as determined by the tester

Design outcomes

Primary

MeasureTime frame
For the imaging area (case one), the superiority of cCeLL – Gastric image diagnosis agreement (70.0%) compared to cCeLL – Gastric image diagnosis agreement (84.3%) received AI diagnosis assistance from cCeLL – Gastric

Secondary

MeasureTime frame
cCeLL-Gastric image shooting time and number of shooting sites;Number of Non-Diagnostic Images

Countries

Korea, Republic of

Contacts

Public ContactSeok Hwi Kim

Ajou University Hospital

seokhwi.kim@gmail.com+82-31-219-6460

Outcome results

None listed

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