Status:
UNKNOWN
Confocal Laser Microendoscopy (CellTouch) for the Diagnosis of Early Gastric Cancer: A Multicenter Clinical Study
Lead Sponsor:
Changhai Hospital
Collaborating Sponsors:
Wuxi Hisky Medical Technology Co Ltd
Conditions:
Early Gastric Cancer
Eligibility:
All Genders
18-70 years
Brief 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 sub...
Detailed Description
Objectives: 1\. Histopathology was used as the gold standard to evaluate the diagnostic performance of CellTouch in the diagnosis of early gastric cancer. Secondary Objectives 1. Using histopatholo...
Eligibility Criteria
Inclusion
- Patients aged between 18 and 70 years;
- Patients who have recently found suspicious lesions by gastroscopy and need further intensive examination;(Suspicious lesions refer to suspected superficial neoplastic lesions visible under white light endoscopy, including elevation type, flatness type and depression type. According to the Paris classification standard);
- Patients who willing to provide written informed consent.
Exclusion
- Patients with absolute contraindications to gastroscopy;
- Patients with advanced gastric cancer;
- Patients who cannot undergo histopathological examination;
- Patients who cannot be given general anesthesia;
- Patients who are pregnant or lactating patients, or prepare to conceive or who are at risk of conception due to lack of effective contraception；
- Patients with history of drug allergies, such as anesthetics, fluorescein sodium, bowel preparation drugs, etc.
Key Trial Info
Start Date :
November 21 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 21 2024
Estimated Enrollment :
578 Patients enrolled
Trial Details
Trial ID
NCT06152783
Start Date
November 21 2023
End Date
November 21 2024
Last Update
December 1 2023
Active Locations (1)
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1
Changhai Hospital
Shanghai, Shanghai Municipality, China, 210000