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Confocal Laser Microendoscopy (CellTouch) for the Diagnosis of Early Gastric Cancer: A Multicenter Clinical Study

NCT06152783 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 578

Last updated 2023-12-01

No results posted yet for this study

Summary

This study is A prospective, randomized, multicenter clinical trial: The study intends to include subjects suspected of early gastric cancer, including 378 subjects with neoplastic lesions and 200 subjects with non-neoplastic lesions. The subjects are divided into two groups by random envelopes, A and B, and the endoscopic diagnosis in different groups is performed in different order (including: White light endoscopy,CellTouch, Magnifying endoscopy with NBI(ME-NBI)). Finally, the gold standard of histopathology was used to evaluate the diagnostic performance of CellTouch in the diagnosis of early gastric cancer.The study hypothesized that the sensitivity and specificity of CellTouch in the diagnosis of early gastric cancer could reach more than 90% and more than 95%.

Conditions

  • Early Gastric Cancer

Sponsors & Collaborators

  • Wuxi Hisky Medical Technology Co Ltd

    collaborator INDUSTRY

  • Changhai Hospital

    lead OTHER

Principal Investigators

  • zhen-dong jin, phD · Changhai Hospital shanghai

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-21
Primary Completion
2024-11-21
Completion
2024-11-21

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06152783 on ClinicalTrials.gov