Recruiting

Ultrasound vs. Fluoroscopy

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06361498

Conditions

Gastrostomy

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Ultrasound Imaging

Study Details

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

Study ID

NCT06361498

Start date

Apr 30, 2024

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Ultrasound Imaging

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

Interventions

Ultrasound Imaging

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

Primary outcome measure

  • Proportion of Ultrasound that Agree with Fluoroscopy with Respect to Identifying the GT Location [ Time Frame: Upon completion of all study image data collection for all participants [approximately 1 year] ]

Central Contacts and Locations

Central contacts

Tracy Carroll

984-974-8157tracy_carroll@med.unc.edu

Desma Jones

9198439463desma_jones@med.unc.edu

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Markeela Lipscomb

9198433670markeela_lipscomb@med.unc.edu

Desma Jones

9198439463desma_jones@med.unc.edu

Principal Investigator:

William Pryor, MD

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • gastrostomy tube
  • ultrasound
  • fluoroscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-06-26.