Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361498
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-03-22
Brief Title:
Ultrasound for Evaluation of Percutaneous G-tube Position
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Accuracy of Ultrasound for the Evaluation of Percutaneous Gastrostomy Tube Position and Leakage
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None