Low-Cost, Single-Use Trans-Nasal Cryotherapy Device for Low-Resource Settings

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PROJECT SUMMARY/ABSTRACT Esophageal cancer is an aggressive disease with a five-year survival rate below 20 percent. The incidence of this cancer has increased dramatically over the last 50 years and is projected to continue increasing at least until 2030. Chronic acid reflux leads to changes in the lining of the esophagus and the development of Barrett’s Esophagus in some patients. Patients with Barrett’s esophagus (BE) have a 50-fold increase in their risk of developing cancer compared to the general population. Over the last two decades, several endoscopic ablation methods have emerged to treat or prevent esophageal cancer. All current ablation technologies are limited to use in the hospital setting. Patients must be sedated while an endoscope is passed through the mouth before the ablation device is delivered. The economic burden of therapy can be prohibitive for all but the most advanced pre-cancerous conditions and cancer. Inconvenience, lack of local providers, and pain are also barriers to wider acceptance, especially in low- and middle-income countries (LMICs). The incidence of esophageal cancer is two to three times higher in black Africans compared to their white counterparts. More recently, multiple new diagnostic modalities have been developed. Several of these options are unsedated and office-based, which will likely identify many more patients since most people with BE go unidentified. Accordingly, it is critical to develop new therapies which would eliminate barriers such as the need for sedation, hospital access, costly endoscopy and ablation systems, and the need to reprocess and repair equipment. CryoScope Medical’s patented single-use ablation device is the first and only device that allows the physician to trans-nasally pass into the esophagus, enabling unsedated cryoablation. Cryoablation is unique in that the therapy has an analgesic effect on tissues and reduces reliance on narcotics post-procedure, compared to Radio Frequency Ablation (RFA). Cryoablation is FDA-approved for esophageal ablation. Combining cyroablation with trans-nasal endoscopy will provide advanced treatment in a low-cost, compact device that will make this therapy accessible to millions of people in low-resource settings. In this project, preliminary device development will be used to develop a complete functional prototype of our novel trans-nasal cryotherapy device. Our approach includes leveraging a validated computational model and 3D printing to rapidly iterate and converge on an optimal design within the key competing constraints. The project involves verification by benchtop testing as well as a physician evaluation study. Specifically, industry-leading endoscopists will receive a prototype of the device to conduct a mock procedure to assess device performance. Iterative development based on the physician evaluation study will guide further improvements to the prototype. Ultimately, as a result of this project, a first-of-its-kind cryoablation device for low-resource settings will be designed and validated against robust success criteria to mitigate the global incidence of esophageal cancer.