Pediatric Percutaneous Ultrasound Gastrostomy Technique

Launched by COAPTECH · Jul 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the PUMA-G Pediatric System, which helps doctors place feeding tubes in children safely and effectively. The device uses ultrasound and magnets to guide the insertion of a gastrostomy tube, which is a tube inserted through the abdomen to provide nutrition directly to the stomach. The goal of this research is to see how well this device works in helping children who need feeding tubes for various medical reasons, such as difficulty swallowing or certain health conditions that prevent them from getting enough nutrition.

To be eligible for this study, children need to be between 0 and 18 years old and meet specific health criteria, such as being a suitable candidate for a gastrostomy tube placement and having certain weight and abdominal thickness measurements. Before participating, a parent or guardian must give their permission. If your child joins the study, they can expect to undergo a procedure to place the feeding tube using the new device, and the research team will monitor their progress closely. It's important to note that there are some health conditions that would exclude participation, such as certain heart issues or if the child has had previous abdominal surgery. Overall, this study aims to improve how feeding tubes are placed in children, making the process safer and more effective.

Gender

ALL

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
• • 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.