Percutaneous Ultrasound Gastrostomy: Clinical Evaluation of a Feeding Tube Placement Method in the Pediatric Population

经皮超声胃造口术（PUG）方法已成为可能，使用 PUMA-G系统。PUMA-G系统由CoapTech，LLC成功开发， SBIR I期支持（R43 DK 115325）导致FDA 510（k）批准在4月用于成人 2019.截至2020年5月1日，PUMA-G成人器械已用于超过100例患者的G管放置。 在美国和加拿大的六个以上的医疗中心，有90名患者没有使用任何设备- 相关不良事件。来自临床医生的强烈需求导致该公司寻求儿科 该系统的应用，以实现安全的，超声引导胃造口术管放置， 孩子与来自三个顶级儿科的儿科程序专家合作， 学术医疗中心，并通过NIH的SBIR计划（R43 DK 12391）的资助， CoapTech对其原始设计进行了广泛的改进，以满足独特的临床需求。 儿科患者的需求，包括婴儿（<10 kg）和儿童（10- 30 kg）。成功 儿科PUMA-G系统的工程设计已在实验室和动物模型中得到证实。 拟议的SBIR第二阶段研究项目将推进儿童尺寸的原型 通过生产阶段转化为医疗级器械，以评价其安全性， 三个主要的儿科学术医疗中心的疗效：费城儿童医院， 国家儿童医院和哥伦比亚纽约长老会医院。假设 成功的结果，该公司将能够使用在申请FDA收集的数据， 帮助向医生销售儿科PUMA-G系统，并提供以下初始支持数据： 相对安全，成本优势，节省时间，并加速婴儿的发育 PUMA-G系统。

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.