Development of a Minimally Invasive Surgical Device for the Treatment of Esophageal Cancer

Period of Performance: 09/01/2015 - 08/31/2016

$278K

Phase 1 SBIR

Recipient Firm

Cell Preservation Services, Inc.
OWEGO, NY 13827
Principal Investigator

Abstract

DESCRIPTION (provided by applicant): The treatment of Esophageal Cancer has experienced a palpable increase in the last few years. While numerous options are currently under investigation, many if not all remain suboptimal. This is critical as it is estimated that in 2013 there were ~450,000 new cases and over 400,000 deaths from esophageal cancer worldwide. In the US alone, there were ~18,000 new cases and over 15,000 deaths from esophageal cancer. Adding to this, ~15% of individuals suffering from gastroesophageal reflux disease (GERD) will develop Barrett's esophagus which has been shown to be a precursor factor for the development of esophageal cancer. This places another >100,000 individuals in the US alone suffering from this chronic disease at an increased risk for development of esophageal cancer annually. While various treatment options currently exist, a number of issues have been reported including the high cost of treatment, patient discomfort, complications, incomplete treatment, and poor efficacy among others. With a 5yr survival rate for esophageal cancer patients of <15%, yielding a reported ~400,000 deaths in 2013 alone, there is an ever growing urgency and compelling need for the development of new strategies and devices to treat both esophageal cancer and Barrett's esophagus. The intent of this project is to develop and characterize an innovative, flexible, closed loop, balloon catheter based endoscopic device (FrostBite) for the treatment of esophageal cancer and Barrett's esophagus, employing a minimally invasive outpatient procedure. The prototype device and preliminary data collected to date strongly support the potential of this approach. The major goals of this Phase 1 proposal are to (1) develop the FrostBite balloon catheter, (2) investigate the cell/molecular response of cancerous and non-cancerous esophageal cells to thermal ablation, (3) develop and test FrostBite in an ex vivo tissue model, and (4) conduct a pilot in vivo study for validation and technology/procedural development. The successful completion of this project will lead to a new technology and therapy for the management of esophageal cancer as well as provide data in support of establishing the thermal dose parameters necessary for optimal clinical application of the proposed device, as well as other ablation technologies, for the treatment of esophageal cancer and Barrett's esophagus. Once completed, this project will provide for an effective, minimally invasive treatment option for individuals suffering from esophageal cancer as well as Barrett's esophagus, contributing to efforts for improving patient survival, quality of life and mitigating risk factors for cancer diagnosis.