New ultrasound technique for placing feeding tubes in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research evaluates the PUMA-G Pediatric System, a new device designed to assist in the safe placement of gastrostomy feeding tubes in pediatric patients using ultrasound guidance instead of ionizing radiation. The study is a multi-center, non-randomized, non-blinded feasibility assessment involving up to 40 patients who will undergo the Percutaneous Ultrasound Gastrostomy (PUG) procedure. Participants will be monitored during their hospital stay and for up to 30 days post-procedure to assess safety and effectiveness compared to traditional methods. The goal is to reduce radiation exposure while ensuring successful tube placement.

Why it matters

Who can join: the full rules

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.

Where it's running

• Children's National Hospital
  Washington D.C., District of Columbia, United States Recruiting
• Nyph/Cumc
  New York, New York, United States Recruiting
• Children's Hospital Of Phildelphia
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Jack Kent, MPH
• Email: jack@coaptech.com
• Phone: 4102151638

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.