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Novel Approach to Surveillance of Gastric Lesions

NCT04251403 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-01-31

No results posted yet for this study

Summary

This will be a pilot study investigating the feasibility of using pressurized irrigation of the stomach mucosa to obtain gastric aspirate cell samples for analysis and identification of premalignant lesions of the stomach.

Conditions

  • Intestinal Metaplasia of Gastric Mucosa
  • Gastric Dysplasia
  • Gastric Cancer
  • Atrophic Gastritis

Interventions

DIAGNOSTIC_TEST

Mucosal Irrigation

Following routine endoscopic evaluation, investigators will utilize the ERBEJET 2 device (ERBE USA Inc), which is commercially available for the treatment of mucosal lesions, to sample cells from the mucosal surface of the stomach. The aspirate will be collected for cytologic/pathologic assessment.

Sponsors & Collaborators

  • New York Presbyterian Hospital

    lead OTHER

Principal Investigators

  • Charles Lightdale, MD · New York Presbyterian - Columbia University Medical Center

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-29
Primary Completion
2021-02-28
Completion
2021-02-28

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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 NCT04251403 on ClinicalTrials.gov