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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:
Participants will be imaging using ultrasound to assess GT positioning before their standard of care fluoroscopic imaging.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound Imaging | Other | This study consists of one group/ All participants will receive ultrasound imaging prior to the standard of care fluoroscopic imaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound Imaging | Device | Participant will receive ultrasound imaging to evaluate the replaced G-tube placement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Ultrasound that Agree with Fluoroscopy with Respect to Identifying the GT Location | 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). | Upon completion of all study image data collection for all participants [approximately 1 year] |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of ultrasound (US) to complete evaluation of GT position | 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. | Upon completion of all study image data collection for all participants [approximately 1 year] |
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Inclusion Criteria:
An individual who presents with a dislodged GT and meets one of the following minor criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tracy Carroll | Contact | 984-974-8157 | tracy_carroll@med.unc.edu | |
| Desma Jones | Contact | 9198439463 | desma_jones@med.unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| William Pryor, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
9 to 36 months following publication.
The investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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