NCT06361498

Ultrasound for Evaluation of Percutaneous G-tube Position

Accuracy of Ultrasound for the Evaluation of Percutaneous Gastrostomy Tube Position and Leakage

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare using ultrasound imaging to look at the position of the gastrostomy tube (GT) against fluoroscopic imaging in pediatric patients who had a recent GT tube replacement. The main questions it aims to answer are: * If ultrasound is just as accurate as fluoroscopy to assess the GT position. * If ultrasound takes less time than fluoroscopy to assessing the GT position. Participants will be imaging using ultrasound to assess GT positioning before their standard of care fluoroscopic imaging.

Detailed description

This clinical trial will address the validity of using ultrasound to evaluate the position of the gastrostomy tube (GT) retention balloon against the clinical gold standard of fluoroscopic tube injection to assess for potential larger studies and the implementation in clinical practice. This study will address the ability to visualize the retention balloon within the gastric lumen, the ability to assess for leakage from the GT within the abdomen, and the relative length of each study to perform.

Conditions

• Gastrostomy

Interventions

Type	Name	Description
DEVICE	Ultrasound Imaging	Participant will receive ultrasound imaging to evaluate the replaced G-tube placement.

Timeline

• Start date: 2024-04-30
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-04-12
• Last updated: 2025-06-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study