Pediatric Percutaneous Ultrasound Gastrostomy Technique

NCT05966311 | Recruiting DMC FDA Device

• 1 other identifier: 220001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Gastrostomy; Gastrostomy Complications; Pediatric Disorder; Ultrasound

Keywords

Gastrostomy; Pediatric Gastrostomy; Device Feasibility; Device Safety; Ultrasound; POCUS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Gastrostomy Procedure Complication Rate

  up to 30 days

• Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Fluoroscopic Time)

  up to 30 days

• Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Dose Area Product)

  up to 30 days

• Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Skin Dose)

  up to 30 days

• Exposure to treatment conditions that pose long term risk to patient health: Anesthesia/Sedative Medications

  up to 30 days

Study Arms (2)

Percutaneous Ultrasound Gastrostomy (PUG)

EXPERIMENTAL

Enrolled subjects will receive the PUG procedure using the PUMA-G Pediatric System performed by an Interventional Radiologist

Device: Percutaneous Ultrasound Gastrostomy

Percutaneous Radiologic Gastrostomy

NO INTERVENTION

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.

Interventions

Percutaneous Ultrasound Gastrostomy DEVICE

Ultrasound guided placement of gastrostomy tube using the PUMA-G Pediatric System

Also known as: Ultrasound Gastrostomy, PUG, PUMA-G Pediatric Procedure

Percutaneous Ultrasound Gastrostomy (PUG)

Eligibility Criteria

• Age: 0 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CoapTech: lead
• Children's Hospital of Philadelphia: collaborator
• Columbia University: collaborator
• Children's National Research Institute: collaborator

Study Sites (3)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Nyph/Cumc

New York, New York, 10019, United States

RECRUITING

Children's Hospital Of Phildelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Central Study Contacts

Jack Kent, MPH

CONTACT

4102151638; jack@coaptech.com

Steven Tropello, MD

CONTACT

4348255184; steven@coaptech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 28, 2023
• Study Start: July 7, 2023
• Primary Completion: August 30, 2024
• Study Completion: December 31, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)