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Procedure
Ultrasound Imaging for Gastrostomy
N/A
Waitlist Available
Led By William Pryor, MD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upon completion of all study image data collection for all participants [approximately 1 year]
Awards & highlights
Study Summary
This trial aims to compare using ultrasound imaging to check the position of a feeding tube in children who recently had it replaced, against the traditional method of using fluoroscopy. It wants to know if ultrasound
Who is the study for?
This trial is for pediatric patients who have recently had a gastrostomy tube (GT) replaced. It's designed to see if ultrasound can be as effective and quicker than fluoroscopy in checking the position of GT tubes.Check my eligibility
What is being tested?
The study is testing the use of ultrasound imaging to assess the positioning of gastrostomy tubes against the standard method, which uses fluoroscopic imaging. The aim is to determine accuracy and speed.See study design
What are the potential side effects?
Since this trial involves non-invasive imaging techniques like ultrasound, there are minimal side effects expected. Some discomfort or minor skin irritation might occur due to contact with the ultrasound gel or equipment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ upon completion of all study image data collection for all participants [approximately 1 year]
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upon completion of all study image data collection for all participants [approximately 1 year]
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of Ultrasound that Agree with Fluoroscopy with Respect to Identifying the GT Location
Secondary outcome measures
Duration of ultrasound (US) to complete evaluation of GT position
Sensitivity of ultrasound (US) to determine the visualization of GT leakage
Specificity of ultrasound (US) to determine the visualization of GT leakage
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ultrasound ImagingExperimental Treatment1 Intervention
This study consists of one group/ All participants will receive ultrasound imaging prior to the standard of care fluoroscopic imaging.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrasound Imaging
2018
Completed Phase 4
~750
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,815 Total Patients Enrolled
William Pryor, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are prospective participants able to enroll in this research study at the present time?
"As per clinicaltrials.gov, the ongoing trial is presently not enrolling new participants. The initial posting date was 4th of January 2024 and it received its most recent update on April 9, 2024. Despite this trial being inactive in terms of recruitment, there are currently nine other trials seeking candidates for participation."
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