Can magnets and ultrasound make child feeding tubes safer?
NCT ID NCT05966311
First seen Jul 31, 2026 · Last updated Jul 31, 2026
Summary
This study tests a new device called the PUMA-G Pediatric System, which uses ultrasound and magnets to help doctors place gastrostomy feeding tubes in children. The goal is to see if the device works well and is safe, by tracking any complications related to the device or the procedure. The study will include 80 children who need a feeding tube, and their outcomes will be compared to standard care methods.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PUMA-G Pediatric System, a device that uses ultrasound and magnets to guide placement of a gastrostomy feeding tube
- What this could lead to
- If successful, this device could offer a safer, less invasive way to place feeding tubes in children, potentially reducing complications compared to standard methods.
- What could go wrong
- This is an early feasibility study, so the device may not work as well as hoped or could have unexpected complications. Results from this small group may not apply to all children.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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0 to 21 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Children's Hospital Of Phildelphia
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Children's National Hospital
RECRUITINGWashington D.C., District of Columbia, 20010, United States
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Nyph/Cumc
RECRUITINGNew York, New York, 10019, United States
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