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NCT Number: NCT06361498

Ultrasound for Evaluation of Percutaneous G-tube Position

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.

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Key information

Conditions

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location status: Recruiting

Location contact

Desma Jones

CONTACT

[email protected]

9198439463

Markeela Lipscomb

CONTACT

[email protected]

9198433670

William Pryor, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound Imaging

Device

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

Primary outcomes

  1. 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]

    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).

Secondary outcomes

  1. Duration of ultrasound (US) to complete evaluation of GT position

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

    Duration of ultrasound to complete the evaluation of the GT position is defined as the length of time necessary to complete a research US evaluation of the GT position using fluoroscopic tube injection as the gold standard.

Study contacts

Contact information is provided by the study sponsor or research team.

Desma Jones

CONTACT

[email protected]

9198439463

Tracy Carroll

CONTACT

[email protected]

984-974-8157

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 12, 2024
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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