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Pediatric Percutaneous Ultrasound Gastrostomy Technique

Recruiting

A Multi-center, Feasibility Study to Evaluate the Use and Safety and of the Pediatric PUMA-G System for Percutaneous Ultrasound Gastrostomy

Who can join

Ages 0 to 21 · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: CoapTech · Participants: 80 · Started: Jul 7, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05966311

Locations in the U.S.

District of ColumbiaChildren's National Hospital, Washington D.C.
New YorkNyph/Cumc, New York
PennsylvaniaChildren's Hospital Of Phildelphia, Philadelphia

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.