Ultrasound-Guided Feeding Tube Placement for Pediatric Disorders

Recruiting at 3 trial locations

Overseen By Steven Tropello, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: CoapTech

Disqualifiers: Fever, Hypertension, Scoliosis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for children needing gastrostomy tube placement due to various conditions like throat abnormalities, neurological issues, bowel diseases, or failure to thrive. Candidates must weigh at least 3kg and have an abdominal wall thickness ≤3cm. They can't participate if they have a fever, abnormal blood pressure or coagulation levels, metallic implants affected by magnets, prior stomach surgeries, recent involvement in other trials, pregnancy or lactation.

Inclusion Criteria

I need a feeding tube due to specific health issues or conditions.

Estimated abdominal wall thickness ≤3cm

Informed consent must be obtained from the patient or a Legally Authorized Representative (ex. parent/guardian) before any study-specific assessment is performed

Exclusion Criteria

Coagulopathy defined by INR > 1.7 or Platelets <50,000

Systolic BP < 80 or > 180 mmHg

Heart Rate < 50 or > 160

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the PUG procedure using the PUMA-G Pediatric System

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the PUG procedure

up to 30 days

During hospital admission until discharge

What Are the Treatments Tested in This Trial?

Interventions

• Percutaneous Ultrasound Gastrostomy

Trial Overview The study tests the PUMA-G Pediatric System—a new device using ultrasound and magnets—to see how well it helps doctors insert feeding tubes in kids. It's designed for safe use during different phases based on the child's weight.

How Is the Trial Designed?

Group I: Percutaneous Ultrasound Gastrostomy (PUG) Experimental Treatment 1 Intervention

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

Group II: Percutaneous Radiologic Gastrostomy Active Control 1 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.

Who Is Running the Clinical Trial?

CoapTech

Lead Sponsor

Trials

4

Recruited

160+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Children's National Research Institute

Collaborator

Trials

227

Recruited

258,000+