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.
Who can participate
Age range0 Years – 21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 da…
What they're measuring
1
PUMA-G Pediatric System Device-Related Complication Rate