The percutaneous ultrasound gastrostomy (PUG) method has been made possible using the PUMA-G System. The PUMA-G System was successfully developed by CoapTech, LLC with SBIR Phase I support (R43 DK115325) leading to FDA 510(k) clearance for use in adults in April 2019. As of May 1, 2020, the PUMA-G adult device has been used for G-tube placement in over 90 patients at more than half a dozen medical centers in the US and Canada with no device- related adverse events. Strong demand from clinicians has led the company to pursue a pediatric application of the system to enable safe, ultrasound guided gastrostomy tube placement for children. In collaboration with expert pediatric proceduralists from three premier pediatric academic medical centers, and via funding from the NIH?s SBIR program (R43DK12391), CoapTech made extensive advances to its original design in order to meet the unique clinical needs of pediatric patients, including infants (<10kg) and children (10-30kg). Successful engineering of the Pediatric PUMA-G System was confirmed in benchtop and animal models. The proposed SBIR Phase II research project will advance the prototype sized for children through phases of production into a medical grade device in order to evaluate its safety and efficacy at three major, pediatric academic medical centers: Children?s Hospital of Philadelphia, Children?s National Hospital, and Columbia New York Presbyterian Hospital. Assuming successful results, the company would be able to use data gleaned in applications to FDA, and to aid in marketing the Pediatric PUMA-G System to physicians with initial supporting data of relative safety, cost advantages, time savings, and to accelerate development of an infant PUMA-G System.
The goal of this Phase II project is to clinically evaluate a novel, ultrasound-based method and device for inserting gastrostomy feeding tubes (G-tubes) in pediatric patients. The Specific Aims in the first year leading up to the study include readying the device, shown feasible in Phase I, for clinical use, and interacting with the FDA in order to obtain an investigational device exemption (IDE) allowing investigators to study the device. The first-in-humans, 40-patient clinical study will take place in the second year of the project with clinical partners at CHOP, Children?s National, and Columbia / New York Presbyterian.
