GastrostomyNCT06361498
Ultrasound for Evaluation of Percutaneous G-tube Position
A study testing Ultrasound Imaging in people with Gastrostomy, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Gastrostomy
- What is being tested?
- Ultrasound Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Markeela Lipscomb, 9198433670, markeela_lipscomb@med.unc.edu
Desma Jones, 9198439463, desma_jones@med.unc.edu
About this study
Official title: Accuracy of Ultrasound for the Evaluation of Percutaneous Gastrostomy Tube Position and Leakage
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.
Read the 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.
- Conditions
- Gastrostomy
- Being tested
- Ultrasound Imaging
- Keywords
- gastrostomy tube, ultrasound, fluoroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound ImagingDevice
Participant will receive ultrasound imaging to evaluate the replaced G-tube placement.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Imaging | Other | This study consists of one group/ All participants will receive ultrasound imaging prior to the standard of care fluoroscopic imaging. Receives: Device: Ultrasound Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Upon completion of all study image data collection for all participants [approximately 1 year]
Secondary outcomes (1)
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.
Measured: Upon completion of all study image data collection for all participants [approximately 1 year]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start30 Apr 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastrostomyStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Pryor, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361498
- Sponsor's protocol ID
- 23-3115
- Status last verified
- Jun 2026
- First submitted
- 22 Mar 2024
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Ultrasound for the Evaluation of Percutaneous Gastrostomy Tube Position and Leakage
- ClinicalTrials.gov ID
- NCT06361498
- Acronym / sponsor ID
- 23-3115
- Conditions
- Gastrostomy
- Keywords
- gastrostomy tube, ultrasound, fluoroscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Imaging | Other | Device: Ultrasound ImagingThis study consists of one group/ All participants will receive ultrasound imaging prior to the standard of care fluoroscopic imaging. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound ImagingParticipant will receive ultrasound imaging to evaluate the replaced G-tube placement. | Device | Ultrasound Imaging |
Primary outcome
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).
1 secondary outcome
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]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Pryor, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Imaging in people with Gastrostomy, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tracy Carroll (984-974-8157, tracy_carroll@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.