Feasibility Study of the PUMA-G Pediatric System for Ultrasound-Guided Feeding Tube Placement in Children and Young Adults

What this Trial Is About

This research evaluates the PUMA-G Pediatric System, a new device designed to help doctors place gastrostomy feeding tubes in children using ultrasound and magnets. The study aims to assess how well this device works and its safety, focusing on reducing radiation exposure compared to standard methods. It is a multicenter, non-randomized feasibility study involving pediatric patients who need gastrostomy tubes. Participants will receive the Percutaneous Ultrasound Gastrostomy PUG procedure using the PUMA-G Pediatric System performed by an Interventional Radiologist. Up to 40 children will undergo this procedure and be monitored during their hospital stay until discharge or for up to 30 days. Their outcomes will be compared to a matched retrospective group who received standard gastrostomy tube placement using radiology guidance. Throughout the study, researchers will collect data on device-related complications, procedure safety, radiation exposure, and medication use. Participants will be observed during hospitalization with follow-up until discharge or 30 days post-procedure. The primary outcome is the rate of device-related complications within 30 days, alongside measurements of radiation exposure and medication effects related to the procedure.

Pediatric Percutaneous Ultrasound Gastrostomy Technique