Status:
RECRUITING
Pediatric Percutaneous Ultrasound Gastrostomy Technique
Lead Sponsor:
CoapTech
Collaborating Sponsors:
Children's Hospital of Philadelphia
Columbia University
Conditions:
Gastrostomy
Gastrostomy Complications
Eligibility:
All Genders
Up to 21 years
Phase:
NA
Brief 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 tube...
Detailed Description
This is a multi-center, non-randomized, non-blinded feasibility study to evaluate the performance and safety of the Percutaneous Ultrasound Gastrostomy (PUG) technique in the pediatric population. A ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05966311
Start Date
July 7 2023
End Date
December 31 2024
Last Update
March 29 2024
Active Locations (3)
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1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
2
Nyph/Cumc
New York, New York, United States, 10019
3
Children's Hospital Of Phildelphia
Philadelphia, Pennsylvania, United States, 19104