Pediatric Percutaneous Ultrasound Gastrostomy Technique
A Multi-center, Feasibility Study to Evaluate the Use and Safety and of the Pediatric PUMA-G System for Percutaneous Ultrasound Gastrostomy
CoapTech
80 participants
Jul 7, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria11
- 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 Criteria15
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Ultrasound guided placement of gastrostomy tube using the PUMA-G Pediatric System
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05966311