MedTrace Logo

High Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia

NCT02029937 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1300

Last updated 2021-01-14

No results posted yet for this study

Summary

The overall objective of this multicenter trial is to determine whether the use of a low-cost, high-resolution microendoscope during diagnostic upper endoscopy can improve the efficiency and accuracy of endoscopic screening for esophageal squamous cell neoplasia. This is a multicenter clinical trial of a novel technology, a miniaturized, lower cost (\< $3, 500) microscope device which can be used during upper endoscopy to image the gastrointestinal epithelium. This high-resolution microendoscope (HRME) was developed by our collaborators at RICE University and provides \>1000X magnified images of the esophageal mucosa.

Conditions

  • Suspected or Known Squamous Cell Neoplasia
  • Prior History of Squamous Cell Dysplasia and /or Neoplasia

Interventions

DRUG

Proflavine, high resolution imaging

5-10 ml of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa. The HRME will then be inserted through the endoscope and gently placed against the mucosa. Imaging of abnormal tissues will be performed.

Sponsors & Collaborators

  • William Marsh Rice University

    collaborator OTHER

  • Baylor College of Medicine

    collaborator OTHER

  • Anandasabapathy, Sharmila, M.D.

    lead INDIV

Principal Investigators

  • Sharmila Anandasabapathy, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • United States
  • China

Study Locations

More Related Trials

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 NCT02029937 on ClinicalTrials.gov