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

经皮超声胃造口术：儿童饲管置入方法的临床评价

• 批准号: 10268249
• 负责人: Howard Carolan
• 金额: $ 77.41万
• 依托单位: COAPTECH, LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-20 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10268249
• 关键词: Abdomen; Academic Medical Centers; Acute; Adult; Adverse event; Air; Anatomy; Animal Model; Animals; Award; Baltimore; Bypass; Caliber; Canada; Canis familiaris; Catheters; Child; Childhood; Clinical; Clinical Research; Clinical Trials; Collaborations; Complication; Coupled; Data; Devices; Endoscopes; Engineering; Enteral Feeding; Esophagus; Failure; Fluoroscopy; Funding; Gastrostomy; Glean; Goals; Grant; Hospitals; Infant; Infant Development; Infection; Investigation; Legal patent; Liquid substance; Lung; Magnetism; Malignant - descriptor; Malignant Neoplasms; Marketing; Medical; Medical center; Methods; New York; Operative Surgical Procedures; Oral cavity; Organ; Pathway interactions; Patients; Pediatric Hospitals; Pediatrics; Perforation; Peritonitis; Pharyngeal structure; Phase; Philadelphia; Physicians; Physics; Pilot Projects; Population; Presbyterian Church; Privatization; Procedures; Production; Puncture procedure; Radiation; Radiology Specialty; Research; Research Personnel; Research Project Grants; Risk; Safety; Savings; Sepsis; Small Business Innovation Research Grant; Sterility; Stomach; System; Techniques; Testing; Thinness; Time; Tube; Ultrasonography; United States; United States National Institutes of Health; X-Ray Computed Tomography; base; cost; design; feeding; first-in-human; hazard; image guided; improved; innovation; magnetic field; novel; nutrition; pediatric patients; programs; prototype; research clinical testing; safety and feasibility; success

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.

经皮超声胃造口术 (PUG) 方法已成为可能 PUMA-G 系统 PUMA-G 系统由 CoapTech, LLC 成功开发。 SBIR 第一阶段支持 (R43 DK115325) 导致 FDA 510(k) 批准在 4 月份用于成人 2019. 截至2020年5月1日，PUMA-G成人设备已用于超过100个国家的G管置入 美国和加拿大超过六家医疗中心的 90 名患者没有任何设备—— 新手的强烈需求促使该公司寻求儿科治疗。 该系统的应用可以安全地在超声引导下放置胃造口管 与来自三个顶级儿科的儿科专家合作。 学术医疗中心，并通过 NIH SBIR 计划 (R43DK12391) 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公斤）和儿童（10-30公斤）成功。 儿科 PUMA-G 系统的工程设计已在台式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 通过医疗级设备的生产阶段，以评估其安全性和 三个主要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。 成功的结果，公司将能够使用在 FDA 申请中收集的数据，以及 帮助向医生推销儿科 PUMA-G 系统，并提供以下初步支持数据 相对安全、成本优势、节省时间、加速婴儿发育 PUMA-G 系统。