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Comparison of pCLE and EB in Gastric Lesion Diagnosis

NCT06389448 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2024-05-07

No results posted yet for this study

Summary

This is a prospective multicenter comparative study, aiming to compare probe-based confocal laser endomicroscopy (pCLE) and endoscopic biopsies in the diagnosis of the whole specific gastric lesion especially for distinguishing low grade intraepithelial neoplasia (LGIN) from high grade intraepithelial neoplasia (HGIN) and create an endoscopic image database for the follow-up research.

Conditions

  • Low Grade Intraepithelial Neoplasia
  • High Grade Intraepithelial Neoplasia
  • Early Gastric Cancer
  • Gastric Intraepithelial Neoplasia

Interventions

DEVICE

pCLE-gastr

After identifying the location of the lesion through white light endoscopy, the pCLE operation is performed to acquire images from the specific gastric lesions, and finally the ESD routine is performed.

Sponsors & Collaborators

  • Huazhong University of Science and Technology

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-04-11
Primary Completion
2026-04-30
Completion
2026-10-31

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 NCT06389448 on ClinicalTrials.gov