Pediatric Percutaneous Ultrasound Gastrostomy Technique

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
• Systolic BP \< 80 or > 180 mmHg
• Heart Rate \< 50 or > 160
• Estimated abdominal wall thickness >3cm
• Coagulopathy defined by INR > 1.7 or Platelets \<50,000
• Presence of a contraindication to being in proximity to a magnet (e.g. implantable metallic device).
• History of prior gastrostomy, gastrectomy (partial or complete), or abdominal trauma or upper-abdominal surgery.
• Scoliosis
• Atypical organ placement including microgastria
• Involvement in other investigational trials within 30 days prior to screening,
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
• Patients with HgB \< 7g/dL, or fluid resuscitated within 48hrs prior, or received blood transfusion within 48hrs prior, or active life threatening GI bleeding
• Esophageal Diseases: Atresia, stricture, caustic ingestion
• Spinal anomalies or atypical organ placement
• Any other medical condition(s) that may put the patient at risk or influence study results in the investigator's opinion, based on the performance of a pre-procedural assessment.