NCT05966311 · CoapTech
Pediatric Percutaneous Ultrasound Gastrostomy Technique
What this study is about
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 experimental device that uses ultrasound and magnets to guide insertion of a feeding tube.
View original scientific description
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.
Interventions
DEVICE
Percutaneous Ultrasound Gastrostomy
Ultrasound guided placement of gastrostomy tube using the PUMA-G Pediatric System
Primary outcome measures
PUMA-G Pediatric System Device-Related Complication Rate
Time frame: up to 30 days
A composite rate of the quantity and severity of device related adverse events will be quantified (i.e. linking complications to what are caused by the device) in the post-procedural period including any additional medical/surgical interventions to resolve
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- 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
- Washington D.C., District of Columbia
- New York, New York
- Philadelphia, Pennsylvania
Collaborators
Children's Hospital of Philadelphia, Columbia University, Children's National Research Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 31, 2026 · Source of record for eligibility and locations