Status:
UNKNOWN
Evaluating Diagnostic Performance of Spectra IMDx System for Detection of Gastric Cancer and Precancerous Lesions
Lead Sponsor:
Endofotonics Pte Ltd
Collaborating Sponsors:
Zhongshan Hospital Xiamen University
Conditions:
Gastric Cancer
Gastric Precancerous Lesion
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the study is to evaluate the diagnostic performance of a Raman spectroscopy analysis device - Spectra IMDx for the detection of gastric cancer and precancerous lesions in vivo.
Detailed Description
This is a prospective, single centre study to assess the diagnostic performance of Spectra IMDx system in detection of gastric cancer and precancerous lesions in subjects with suspected gastric intrae...
Eligibility Criteria
Inclusion
- The subject is older than 18 years of age.
- The subject is undergoing upper GI endoscopy for suspected intraepithelial neoplasia or gastric cancer lesions (less than 20mm)
- The subject must have personally signed and dated the patient informed consent form indicating that he/she has been informed of all pertinent aspects of the study.
- The subject must be willing and able to comply with all study procedures.
Exclusion
- The subject has bleeding disorders, such as haemophilia, in whom biopsies are contraindicated.
- The subject shows presence of active gastrointestinal bleeding or coagulopathy precluding biopsies.
- The subject has rare gastric malignancies such as gastrointestinal stromal tumors (GISTs), lymphomas and neuroendocrine tumors （NETs）.
- The subject is pregnant.
- The subject with liver cirrhosis, impaired renal function, acute gastrointestinal (GI) bleeding, esophageal varices, jaundice, and GI post-surgery
- The subject with severe co-morbid illness, such as end-stage renal failure (ESRF), congestive cardiac failure (CCF), severe osteoarthritis (OA) and rheumatoid arthritis (RA) requiring long term non-steroidal anti-inflammatory drug (NSAID) therapy
- The subject has other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results and in the judgment of the investigator would make the subject unsuitable for entry into the study
- The subject on regular anti-coagulant prophylaxis such as warfarin must be able to undergo a five-day washout period before gastroscopy. The subject on aspirin, ticlopidine and clopidogrel must be able to undergo a one-week washout period before gastroscopy. The subject's physician or study co-investigator will exercise their clinical judgement to ensure subject's safety.
- The subject is unwilling or unable to provide signed informed consent.
Key Trial Info
Start Date :
October 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2021
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT04835246
Start Date
October 7 2019
End Date
July 31 2021
Last Update
April 15 2021
Active Locations (1)
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1
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China, 361004