Pediatric Percutaneous Ultrasound Gastrostomy Technique

Status Recruiting

Clinical Trial Summary

The purpose of this research study is to test a new device called the PUMA-G Pediatric System. The research will measure if the device works well to safely aid doctors placing gastrostomy feeding tubes in children. The PUMA-G Pediatric System is an investigational device that uses ultrasound and magnets to guide insertion of a feeding tube.

Clinical Trial Description

This is a multi-center, non-randomized, non-blinded feasibility study to evaluate the performance and safety of the Percutaneous Ultrasound Gastrostomy (PUG) technique in the pediatric population. A common method for placing gastrostomy tubes currently uses ionizing radiation to aid doctors in procedural steps. Excess radiation usage may present long-term risks to pediatric patients. The PUG procedure, using the PUMA-G Pediatric System, primarily uses ultrasound to guide gastrostomy feeding tube placement. Up to 40 patients will be enrolled in the study and receive the PUG procedure using the PUMA-G Pediatric System. Following the procedure, patients will be followed during their hospital admission until discharge or up to 30 days. Data will be collected to assess how safe the procedure was and if the procedure used less radiation. Study subjects will be compared to a matched, retrospective cohort of patients who received standard of care gastrostomy tube placement by Interventional Radiology. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05966311
Study type	Interventional
Source	CoapTech
Contact	Jack Kent, MPH
Phone	4102151638
Email	jack@coaptech.com
Status	Recruiting
Phase	N/A
Start date	July 7, 2023
Completion date	December 31, 2024

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