Clinical trial NCT05966311: Pediatric Percutaneous Ultrasound Gastrostomy Technique
Official title: A Multi-center, Feasibility Study to Evaluate the Use and Safety and of the Pediatric PUMA-G System for Percutaneous Ultrasound Gastrostomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrostomy
Gastrostomy Complications
Pediatric Disorder
Ultrasound
Keywords: Gastrostomy
Pediatric Gastrostomy
Device Feasibility
Device Safety
Ultrasound
POCUS
Lead sponsor: CoapTech
Sponsor class: INDUSTRY
Collaborators: name: Children's Hospital of Philadelphia
name: Columbia University
name: Children's National Research Institute
First posted: 2023-07-28
Enrollment: 80
Sex: ALL
Minimum age (years): 0
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants prospectively enrolled are assigned to the interventional treatment procedure using the PUMA-G Peds System. A retrospective comparator is used as a means of comparing outcomes with a similar, historical cohort of patients who received the standard of care treatment procedure.
Primary purpose: TREATMENT

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 tubes in children. The PUMA-G Pediatric System is an investigational device that uses ultrasound and magnets to guide insertion of a 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 common method for placing gastrostomy tubes currently uses ionizing radiation to aid doctors in procedural steps. Excess radiation usage may present long-term risks to pediatric patients. The PUG procedure, using the PUMA-G Pediatric System, primarily uses ultrasound to guide gastrostomy feeding tube placement.

Up to 40 patients will be enrolled in the study and receive the PUG procedure using the PUMA-G Pediatric System. Following the procedure, patients will be followed during their hospital admission until discharge or up to 30 days. Data will be collected to assess how safe the procedure was and if the procedure used less radiation. Study subjects will be compared to a matched, retrospective cohort of patients who received standard of care gastrostomy tube placement by Interventional Radiology.

Eligibility 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.

Primary outcomes:
measure: PUMA-G Pediatric System Device-Related Complication Rate
timeFrame: up to 30 days
Secondary outcomes:
measure: Gastrostomy Procedure Complication Rate
timeFrame: up to 30 days
measure: Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Fluoroscopic Time)
timeFrame: up to 30 days
measure: Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Dose Area Product)
timeFrame: up to 30 days
measure: Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Skin Dose)
timeFrame: up to 30 days
measure: Exposure to treatment conditions that pose long term risk to patient health: Anesthesia/Sedative Medications
timeFrame: up to 30 days
measure: Exposure to treatment conditions that pose long term risk to patient health: Antibiotic Medications
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
city: New York
country: United States
facility: Nyph/Cumc
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital Of Phildelphia
state: Pennsylvania
Study officials:
References: