University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Location status: Recruiting
Location contact
Desma Jones
CONTACT
Markeela Lipscomb
CONTACT
William Pryor, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06361498
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.
Interested in participating?
Request InfoUp to 18 year
All sexes
Interventional
Not applicable
Chapel Hill, North Carolina, 27599, United States
Location status: Recruiting
Desma Jones
CONTACT
Markeela Lipscomb
CONTACT
William Pryor, MD
PRINCIPAL_INVESTIGATOR
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.
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:
Exclusion criteria
Participant will receive ultrasound imaging to evaluate the replaced G-tube placement.
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).
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.
Contact information is provided by the study sponsor or research team.
Desma Jones
CONTACT
Tracy Carroll
CONTACT
University of North Carolina, Chapel Hill
Other
Accuracy of Ultrasound for the Evaluation of Percutaneous Gastrostomy Tube Position and Leakage
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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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