Ultrasound-Guided Feeding Tube Placement for Pediatric Disorders

Recruiting at 4 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?

This trial tests a new device called the PUMA-G Pediatric System, designed to help doctors place feeding tubes in children more safely using ultrasound and magnets. The goal is to determine if this new method, known as Percutaneous Ultrasound Gastrostomy, performs as well as the current standard procedure. The study seeks children who need a gastrostomy tube due to conditions like cerebral palsy, cystic fibrosis, or short bowel syndrome. Participants must not have had certain surgeries or medical conditions that could interfere with the trial. As an unphased trial, it offers a unique opportunity to contribute to advancements in pediatric care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the PUMA-G Pediatric System is safe for use in children?

Research has shown that Percutaneous Ultrasound Gastrostomy (PUG) provides a safe method for placing feeding tubes. Studies indicate that PUG matches the safety of other common methods, such as percutaneous endoscopic gastrostomy (PEG) and percutaneous radiologic gastrostomy (PRG). One study found that all PUG procedures succeeded, even when performed bedside in the ICU. Another study highlighted PUG as both safe and cost-effective compared to traditional methods.

Overall, previous patients have tolerated PUG well, with no major safety issues reported. This suggests that the PUG procedure using the PUMA-G Pediatric System is likely to be well-tolerated as well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Percutaneous Ultrasound Gastrostomy (PUG) technique because it offers a potential alternative to traditional methods like Percutaneous Endoscopic Gastrostomy (PEG) and Percutaneous Radiologic Gastrostomy (PRG). The PUG method uses real-time ultrasound guidance, which can enhance precision and safety by allowing interventional radiologists to visualize soft tissues and avoid critical structures during the procedure. This approach might reduce the risk of complications and improve patient outcomes, making it a promising option for kids needing feeding tube placement.

What evidence suggests that the PUMA-G Pediatric System is effective for ultrasound-guided feeding tube placement in children?

Research has shown that Percutaneous Ultrasound Gastrostomy (PUG), which participants in this trial will receive, is a promising method for placing feeding tubes in children. Studies have found that children who underwent PUG procedures spent up to 8.7 fewer days in the hospital. Ultrasound allows doctors to see inside the body clearly, reducing the risk of injury during the procedure. Previous research also highlights that gastrostomy tubes perform well in the long term for children, especially those with neurological conditions. Overall, PUG appears to be a safe and effective option for placing feeding tubes in children. ^{1 2 4 6 7}

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+

Citations

1. journals.sagepub.com journals.sagepub.com/doi/10.1177/23320249251321010

Percutaneous Ultrasound Gastrostomy: A Safe Alternative ... In this trial, the patients who underwent PUG tube procedures had shorter hospital stays, as evidenced by reductions of 5.0 and 8.7 days. The ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05966311

Pediatric Percutaneous Ultrasound Gastrostomy Technique This is a multi-center, non-randomized, non-blinded feasibility study to evaluate the performance and safety of the Percutaneous Ultrasound Gastrostomy (PUG) ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40142176/

Long-Term Outcomes of Children Receiving Percutaneous ... This study confirmed the durability of gastrostomy tube feeding in children with neurological impairment, noting a low prevalence of fundoplication but a high ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8902105/

Percutaneous ultrasound gastrostomy (PUG) overview ... Ultrasound guidance via PUG now makes visceral injuries avoidable in percutaneous gastrostomy. For example, Figure 1 shows clear tissue planes and the internal ...

5. researchgate.net researchgate.net/publication/389904004_Percutaneous_Ultrasound_Gastrostomy_A_Safe_Alternative_to_PEG_Tubes

Percutaneous Ultrasound Gastrostomy: A Safe Alternative ... Primary outcomes were length of stay (LOS) and total hospital costs. Results: A total of 88 patients were included in the analysis, 45 patients ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8502161/

Percutaneous ultrasound gastrostomy (PUG) Results. All PUG procedures were successful, including 3/25 [12%] performed bedside within the ICU. There was no significant difference between PUG and PRG ...

7. ctv.veeva.com ctv.veeva.com/study/pediatric-percutaneous-ultrasound-gastrostomy-technique

Pediatric Percutaneous Ultrasound Gastrostomy Technique This is a multi-center, non-randomized, non-blinded feasibility study to evaluate the performance and safety of the Percutaneous Ultrasound ...