A Multi-center, Feasibility Study to Evaluate the Use and Safety and of the Pediatric PUMA-G System for Percutaneous Ultrasound Gastrostomy
CoapTech
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.
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 th…
Eligibility
- Age range
- 0–21 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Informed consent must be obtained from the patient or a Legally Authorized Representative (ex. parent/guardian) before any study-specific assessment is performed * Weight ≥5 (Phase 0, Phase 1, Phase 2) * Weight ≥3kg and \<10kg (Phase 3) * Estimated abdominal wall thickness ≤3cm * Indication for gastrostomy tube placement, with or without jejunal access tubing via gastrostomy tract, determined to be present for any of the following reasons: * Anatomic: Ear, nose, or throat abnormalities (Pierre-Robin sequence cleft lip palate) * Neurologic: Head trauma, Cerebral palsy * B…
Interventions
- DevicePercutaneous Ultrasound Gastrostomy
Ultrasound guided placement of gastrostomy tube using the PUMA-G Pediatric System
Locations (3)
- Children's National HospitalWashington D.C., District of Columbia
- Nyph/CumcNew York, New York
- Children's Hospital Of PhildelphiaPhiladelphia, Pennsylvania