High Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia

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.

Timeline

Start

2014-01

Primary completion

2021-12

Completion

2021-12

Outcome

Met primary endpoint

paper HRME increased efficiency in screening: diagnostic yield (neoplastic/total biopsies) improved from 20.0% (95% confidence interval [CI], 12.7-29.2) to 51.7% (95% CI, 32.5-70.6) PMID 39477026 ↗

paper A low-cost microendoscope improves the efficiency and clinical impact of ESCN screening and surveillance PMID 39477026 ↗

Publications

• Tan MC, Li Z, Patel KK, Zhang F, Yu X, Wang X, Rosen DG, Dawsey SM, Xue L, Hur C, Schwarz RA, Vohra I, Tang Y, Wu M, Wang T, Carns J, Xu H, Richards-Kortum RR, Wang G, Anandasabapathy S. A High-Resolution Microendoscope Improves Esophageal Cancer Screening and Surveillance: Implications for Underserved Global Settings Based on an International Randomized Controlled Trial. Gastroenterology. 2025 Mar;168(3):496-507.e3. doi: 10.1053/j.gastro.2024.10.025. Epub 2024 Oct 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Proflavine	Diagnostic / imaging agent	0.01 %	Topical
Subject	Proflavine	Diagnostic / imaging agent	5 ml	Topical
Subject	Proflavine	Diagnostic / imaging agent	10 ml	Topical

Indications