Ultrasound for Evaluation of Percutaneous G-tube Position

NCT ID: NCT06361498

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2026-06-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ultrasound Imaging

This study consists of one group/ All participants will receive ultrasound imaging prior to the standard of care fluoroscopic imaging.

Group Type: OTHER

Ultrasound Imaging

Intervention Type: DEVICE

Participant will receive ultrasound imaging to evaluate the replaced G-tube placement.

Interventions

Ultrasound Imaging

Participant will receive ultrasound imaging to evaluate the replaced G-tube placement.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

An individual who presents with a dislodged GT and meets one of the following minor criteria:

• Surgical GT placement less than 90 days from presentation
• Traumatic GT dislodgement/removal
• Recent stoma dilation
• Clinician uncertainty about position of GT placement

Exclusion Criteria

• An individual >18 years of age
• Acutely ill patients defined as hemodynamically unstable defined as any child who has abnormal vital signs or disruption of vital functions (i.e. airway, breathing, circulation, mental function). Vital signs are based on patient age. Initial assessment of clinical patient stability will be provided by the ordering/referring provider.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Pryor, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hannah P Mignosa-Martin

Role: CONTACT

hannah_mignosa@med.unc.edu

9198431670

Desma Jones

Role: CONTACT

desma_jones@med.unc.edu

9198439463

Facility Contacts

Markeela Lipscomb

Role: primary

markeela_lipscomb@med.unc.edu

919-843-3670

Desma Jones

Role: backup

desma_jones@med.unc.edu

9198439463

Other Identifiers

23-3115

Identifier Type: -

Identifier Source: org_study_id