Ultrasound for Evaluation of Percutaneous G-tube Position

NCT06361498 | Recruiting FDA Device

• 1 other identifier: 23-3115
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrostomy

Keywords

gastrostomy tube; ultrasound; fluoroscopy

Outcome Measures

Primary Outcomes (1)

• Proportion of Ultrasound that Agree with Fluoroscopy with Respect to Identifying the GT Location

  Proportional accuracy of ultrasound in identifying the gastrostomy tube (GT) balloon location based on the readers' (radiologists) ability to use the ultrasound to locate the GT balloon in comparison with the gold standard (fluoroscopic tube injection).

  Upon completion of all study image data collection for all participants [approximately 1 year]

Secondary Outcomes (3)

• Sensitivity of ultrasound (US) to determine the visualization of GT leakage

  Upon completion of all study image data collection for all participants [approximately 1 year]

• Specificity of ultrasound (US) to determine the visualization of GT leakage

  Upon completion of all study image data collection for all participants [approximately 1 year]

• Duration of ultrasound (US) to complete evaluation of GT position

  Upon completion of all study image data collection for all participants [approximately 1 year]

Study Arms (1)

Ultrasound Imaging

OTHER

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

Device: Ultrasound Imaging

Interventions

Ultrasound Imaging DEVICE

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

Ultrasound Imaging

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• William Pryor, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah P Mignosa-Martin

CONTACT

9198431670; hannah_mignosa@med.unc.edu

Desma Jones

CONTACT

9198439463; desma_jones@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 12, 2024
• Study Start: April 30, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9 to 36 months following publication.
• Access Criteria: The investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Locations

US (1)