Pediatric Percutaneous Ultrasound Gastrostomy Technique
Trial Parameters
Brief 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.
Eligibility Criteria
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 * Bowel Disease: Short Bowel syndrome, intestinal dysmotility, inflammatory bowel disease, malabsorption * Failure to Thrive: Cystic Fibrosis, Cholestasis, AID, Chronic renal failure, and food refusal * Patient determined to be an appropriate candidate for PUG, PEG, or PRG by the clinical care team * Anticipated discharge \> 24 hrs following gastrostomy Exclusion Criteria: * Temperature ≥ 38 C * Systo