Pediatric Percutaneous Ultrasound Gastrostomy Technique

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastrostomy; Pediatric Disorder; Ultrasound; Gastrostomy Complications
• Intervention / Treatment: Device: Percutaneous Ultrasound Gastrostomy

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jack Kent, MPH; Phone Number: 4102151638; Email: jack@coaptech.com
• Study Contact Backup: Name: Steven Tropello, MD; Phone Number: 4348255184; Email: steven@coaptech.com

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Recruiting
      • Children's National Hospital
      • Contact: Bhupender Yadav, MD; Phone Number: 202-476-4252; Email: byadav@childrensnational.org
  • New York
    • New York, New York, United States, 10019
      • Recruiting
      • Nyph/Cumc
      • Contact: Joshua Weintraub, MD; Phone Number: 212-326-8874; Email: jw750@cumc.columbia.edu
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Children's Hospital Of Phildelphia
      • Contact: Anne Marie Cahill, MD; Phone Number: 267-425-7118; Email: CAHILL@chop.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Percutaneous Ultrasound Gastrostomy (PUG); Enrolled subjects will receive the PUG procedure using the PUMA-G Pediatric System performed by an Interventional Radiologist	Device: Percutaneous Ultrasound Gastrostomy; Ultrasound guided placement of gastrostomy tube using the PUMA-G Pediatric System; Other Names: Ultrasound Gastrostomy; PUG; PUMA-G Pediatric Procedure
No Intervention: Percutaneous Radiologic Gastrostomy; 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?

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

Collaborators and Investigators

• Sponsor: CoapTech
• Collaborators: Children's Hospital of Philadelphia; Columbia University; Children's National Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2023
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: July 27, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Ultrasound; Device Safety; Gastrostomy; Device Feasibility; POCUS; Pediatric Gastrostomy
• Other Study ID Numbers: 220001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes