MedTrace Logo

Evaluating Diagnostic Performance of Spectra IMDx System for Detection of Gastric Cancer and Precancerous Lesions

NCT04835246 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2021-04-15

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Spectra IMDx system

The Spectra IMDx system is intended to be used in conjunction with conventional white light endoscopy in upper gastrointestinal endoscopic procedure to identify patients with high risk of developing and/or having gastric cancer and it is intended for use on patients above and equal to the age of 18.

Sponsors & Collaborators

  • Zhongshan Hospital Xiamen University

    collaborator OTHER

  • Endofotonics Pte Ltd

    lead INDUSTRY

Principal Investigators

  • Hongzhi Xu, MD, PhD · Zhongshan Hospital Xiamen University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-07
Primary Completion
2021-05-31
Completion
2021-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT04835246 on ClinicalTrials.gov