Pediatric Percutaneous Ultrasound Gastrostomy Technique

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multi-center, Feasibility Study to Evaluate the Use and Safety and of the Pediatric PUMA-G System for Percutaneous Ultrasound Gastrostomy

Conditions
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Gastrostomy, Gastrostomy Complications, Pediatric Disorder, Ultrasound

Intervention / Treatment
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* Device: Percutaneous Ultrasound Gastrostomy


Participation Criteria
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Eligibility Criteria
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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 ≥10 (Phase 0, Phase 1, Phase 2) Weight ≥3kg and <10kg (Phase 3) Estimated abdominal wall thickness ≤3cm Indication for gastrostomy tube placement 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.

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Percutaneous Ultrasound Gastrostomy (PUG)<br>Enrolled subjects will receive the PUG procedure using the PUMA-G Pediatric System performed by an Interventional Radiologist | Device: Percutaneous Ultrasound Gastrostomy<br>* Ultrasound guided placement of gastrostomy tube using the PUMA-G Pediatric System<br>* Other names: PUMA-G Pediatric Procedure;|
| No Intervention: Percutaneous Radiologic Gastrostomy<br>A matched, retrospective control cohort of patients previously admitted to hospital for the placement of gastrostomy tubes by Interventional Radiology will be used to compare performance of the PUMA-G Pediatric System to standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PUMA-G Pediatric System Device-Related Complication Rate | 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 | up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrostomy Procedure Complication Rate | The rate of other complications during the immediate procedural period between the PUG placement and a historical cohort of matched controls who underwent gastrostomy placement using standard of care Interventional Radiologic gastrostomy tube placement method | up to 30 days | 
| Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Fluoroscopic Time) | The quantity of ionizing radiation used during the PUG procedure will be compared to a historical cohort of matched controls who underwent gastrostomy placement using the standard of care Interventional Radiologic gastrostomy tube placement method. Quantities of procedural ionizing radiation will be measured by total fluoroscopic time (min). | up to 30 days | 
| Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Dose Area Product) | The quantity of ionizing radiation used during the PUG procedure will be compared to a historical cohort of matched controls who underwent gastrostomy placement using the standard of care Interventional Radiologic gastrostomy tube placement method. Quantities of procedural ionizing radiation will be measured by dose area product (microGy-m2). | up to 30 days | 
| Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Skin Dose) | The quantity of ionizing radiation used during the PUG procedure will be compared to a historical cohort of matched controls who underwent gastrostomy placement using the standard of care Interventional Radiologic gastrostomy tube placement method. Quantities of procedural ionizing radiation will be measured by skin dose (mGy). | up to 30 days | 
| Exposure to treatment conditions that pose long term risk to patient health: Anesthesia/Sedative Medications | The quantity of anesthesia/sedative medications used during the PUG procedure will be compared to a historical cohort of matched controls who underwent gastrostomy placement using the standard of care Interventional Radiologic gastrostomy tube placement method. Medications and total procedural dosages will be quantified. | up to 30 days | 
| Exposure to treatment conditions that pose long term risk to patient health: Antibiotic Medications | The quantity of antibiotic medications used during the PUG procedure and in the post-procedural timeframe will be compared to a historical cohort of matched controls who underwent gastrostomy placement using the standard of care Interventional Radiologic gastrostomy tube placement method. Medication and dosage will be measured. | up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrostomy, Pediatric Gastrostomy, Device Feasibility, Device Safety, Ultrasound, POCUS