Low Cost Tethered Capsule Endoscope with High-Resolution Digital Chromoscopy for Barrett's Screening

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Abstract Esophageal cancer is the 6th leading cause of cancer death worldwide; rates of esophageal adenocarcinoma (EAC) have risen exponentially over the past 4 decades. When EAC is diagnosed at a late stage, 5‐year survival rates are dismal (∼18%). Because of this, increased effort has focused on early detection and treatment of Barrett's esophagus (BE), the only recognized precursor of EAC. Indeed, when esophageal neoplasia is diagnosed at an early stage (Barrett's with high grade dysplasia/intramucosal cancer) and treated endoscopically, 5‐year survival rates exceed 98%. Early detection is currently performed by standard upper endoscopy with high‐definition White Light (WL) and Narrow Band Imaging (NBI) which has been shown to have a sensitivity of >90%. Nonetheless, standard endoscopy is invasive, expensive (commercial scopes >$25,000) AND requires extensive infrastructure for patient exam/sedation. Capsule endoscopy is an appealing alternative option for low‐resource regions (and community practices in the US) that lack infrastructure and expert clinicians. Unfortunately, current commercially available capsule systems lack the spatial‐ resolution to accurately diagnose BE, are single‐use, and are costly (>$25,000 per system, >$350 per single‐use capsule). The goal of this proposal is to develop a lower‐cost , high‐resolution capsule endoscopy system to allow less experienced providers to screen for BE in community‐based settings in the US and low‐resource settings globally. The ScanCap system has two components: a reusable, $75 tethered capsule that is swallowed to collect images of the mucosa and $1000 supporting system to manipulate and display the collected data on a tablet computer. After the capsule is swallowed, the tether is withdrawn and high resolution, NBI images are collected from the entire esophagus. Unlike existing capsule endoscopes, our design enables high resolution side‐viewing of the lumen, with circumferential scanning of the esophagus through guided rotation of the mirror within the capsule as it is withdrawn. The system is portable, battery operated, designed for use by non‐physicians in underserved settings, and can acquire high definition images with NBI to enable visualization of capillary loops. Here, we aim to (1) develop and refine a tethered capsule endoscope (ScanCap) with NBI for esophageal cancer screening, (2) compare the image quality of ScanCap's NBI images to gold‐standard, high‐definition endoscopy with NBI using resected ex vivo samples, (3) evaluate the functional & imaging capabilities and safety of the device in an IACUC‐approved porcine study, and (4) test the imaging performance of ScanCap in a pilot study of 10 patients with documented BE in an IRB‐approved human study. Our multi‐disciplinary team will leverage advances in consumer grade image sensors, injection molded lenses, and optical scanner technology to refine and evaluate a reusable capsule that rivals the performance of high‐definition, state‐of the art NBI endoscopes AND is more cost‐effective (and higher‐resolution) than commercial swallowed capsule systems. The end result will be a lower‐cost, reusable, high quality platform for esophageal cancer screening in community‐based settings in the US and rural, underserved regions worldwide.