New ultrasound technique for placing feeding tubes in children
A Multi-center, Feasibility Study to Evaluate the Use and Safety and of the Pediatric PUMA-G System for Percutaneous Ultrasound Gastrostomy
This study is testing a new ultrasound device to see if it can help safely place feeding tubes in children without using radiation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 0 Years to 21 Years |
| Sex | All |
| Sponsor | CoapTech Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 3 sites (Washington, District of Columbia and 2 other locations) |
| Trial ID | NCT05966311 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include pediatric patients weighing between 3kg and 10kg who require gastrostomy tube placement for various medical conditions.
Not a fit: Patients with elevated body temperature or certain medical conditions that contraindicate the procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could significantly reduce radiation exposure in children requiring gastrostomy tubes.
How similar studies have performed: While the use of ultrasound in medical procedures is established, this specific approach for gastrostomy tube placement is novel and has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Washington, District of Columbia and 2 other locations
- Children's National Hospital — Washington, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.