Percutaneous Ultrasound Gastrostomy: Clinical Evaluation of a Novel Method for Feeding Tube Placement

The goal of this project is to test a potentially safer, more accessible method for placement of gastrostomy feeding tubes. Millions of patients worldwide require enteral nutrition, and hundreds of thousands of gastrostomy (feeding tube placement) procedures are performed annually in the United States alone. Key patient populations receiving gastrostomy procedures include Medicare enrollees in the US, pre-term infants in developing nations, and individuals managing chronic conditions which are increasing in incidence, such as cancer and stroke. The current standard of practice for placement of nearly all feeding tubes worldwide is called the Percutaneous Endoscopic Gastrostomy (PEG) method. PEG is costly, complex, and potentially risky to perform, as it is performed in a surgical suite about 85% of the time, requiring specialty providers and sophisticated imaging instruments. We have invented a new device and method, using magnets and low-cost ultrasound, called the Point-of-Care Ultrasound Magnet Aligned Gastrostomy (PUMA-G) device, which will improve and simplify the gastrostomy procedure on many dimensions. The PUMA-G device is applied using the Percutaneous Ultrasound Gastrostomy (PUG) procedure. The most important difference between our method and PEG, is that the PUMA-G device will allow 80% of all gastrostomy procedures to be performed at the patient’s bedside - without specialist consultants, expensive imaging, and surgical suite time (for the remaining 20% of cases, the PUMA-G device will be contraindicated, and a conventional PEG may be performed). Migration of methods from the surgical theatre to the patient bedside has successfully occurred for many different specialty procedures over the previous two decades, and in each instance has led to substantially reduced cost and improved patient satisfaction, with comparable or better safety outcomes. The PUMA-G device has demonstrated feasibility in live GLP canine studies, human cadavers, and benchtop studies, and has a clear regulatory pathway laid out through meetings held between CoapTech and the FDA. In this Phase 2 SBIR project we will conduct a clinical study in 40 critical care patients to establish safety and feasibility of the procedure in a live setting. We will also develop a rigorous Human Factors-informed training program for the use of the PUMA-G device. Successful completion of this project will form the basis for safety and cost justifications and provide vital data for clinical adoption in order to bring this new method significantly closer to improving outcomes and experience for patients worldwide.The goals of this project are to launch a pilot clinical safety study supporting dissemination of a novel method for safer, more accessible placement of gastrostomy feeding tubes and to develop a rigorous Human Factors-informed training program for the use of the novel Point- of-Care Ultrasound Magnet Aligned Gastrostomy (PUMA-G) device. The current standard of practice worldwide is costly, introduces undue risk, and requires specialty providers and imaging instruments. We have invented a new device and method, which will improve and simplify the gastrostomy procedure on many dimensions and has a clear regulatory pathway laid out with supporting guidance by the FDA.