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Clinical Trials in the USA / NCT05966311
Recruiting Not applicable

Pediatric Percutaneous Ultrasound Gastrostomy Technique

NCT05966311 · tracked via the Priya Life Science USA tracker
Sponsor
CoapTech
Phase
Not applicable
Started
2023-07-07
Last updated
2026-07-31

Condition(s) studied

GastrostomyGastrostomy ComplicationsPediatric DisorderUltrasound

Investigational drug(s) / intervention(s)

Percutaneous Ultrasound Gastrostomy

Percutaneous Ultrasound Gastrostomy: Ultrasound guided placement of gastrostomy tube using the PUMA-G Pediatric System

Study 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

Sex
ALL
Min age
0 Years
Max age
21 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (3)

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

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05966311 on ClinicalTrials.gov ↗ ← All trials in the USA