Enteral NutritionNCT04601571
Confirming Feeding Tube Position Using CORTRAK
A study testing CORTRAK Stylet in people with Enteral Nutrition, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
This study will compare the accuracy of the CORTRAK enteral access system (CEAS) to x-ray for the determination of feeding tube position within the abdomen. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Enteral Nutrition
- What is being tested?
- CORTRAK Stylet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- CORTRAK feeding tube placed as part of clinical care
- Getting xray for any reason
- CORTRAK Stylet available in the room
- Pediatric patients (Aged 17 or younger)
Who cannot join
- -CORTRAK Stylet has been misplaced
Trial locations and contacts
1 site in 1 country.
United States1 site
University Health Systems Hospital
San Antonio, Texas, 78229
About this study
Official title: Confirming Feeding Tube Position Using the CORTRAK Enteral Access System
This study will compare the accuracy of the CORTRAK enteral access system (CEAS) to x-ray for the determination of feeding tube position within the abdomen.
Read the detailed description
In the inpatient pediatric care area (PICU, PCCU, PIMU, ACU), when an x-ray is performed for any reason and a patient has a CORTRAK feeding tube, a provider from the research team will re-insert the small, individualized, flexible stylet back into the patient's feeding tube and document the position of the tube on the CORTRAK display monitor. The x-ray will be obtained by current standard of care and the tube location on x-ray will be compared to the tube location on the CORTRAK monitor. The x-ray will only be obtained as part of the routine care decided by the medical team, the patient will not receive any additional x-rays for this study.
- Conditions
- Enteral Nutrition
- Being tested
- CORTRAK Stylet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CORTRAK StyletDevice
Also called Feeding tube stylet
The stylet is a component of the CORTRAK feeding tube system used to confirm the correct placement of the feeding tube
| Study group | Role | What they receive |
|---|---|---|
| Feeding Tube Placement using CORTRAK stylet | Active comparator | Subjects will already have a feeding tube placed and are undergoing X-rays for placement confirmation. Receives: Device: CORTRAK Stylet |
| Feeding Tube Placement using X-Ray | No intervention | Routine X-ray is used to confirm feeding tube placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmation of correct placement of the Feeding tube
An x-ray will be obtained first as per standard of care and within 4 hours of the x-ray, the research procedure will occur. Following slow and careful removal of the stylet, the research team member will ensure there has been no movement of the feeding tube per the depth indicators on the outside of the tube. The location of the tube as it appears on the CORTRAK monitor will be documented and the location of the tube on x-ray will be documented. This will be reported as number of times that the tube is correctly placed.
Measured: Baseline to removal of feeding tube (on average 10-14 days)
Secondary outcomes (1)
Number of Radiographs required for placement
Count of radiographs used to ensure correct placement of enteral feeding tube
Measured: Baseline to removal of feeding tube (on average 10-14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study startMar 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2026 (estimated)
Why it stopped: Despite the study being in active enrollment since 2020, the research staff has not been available to enroll patients because of lack of trained nursing staff.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral NutritionStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A non-inferior cohort study design
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Meyer, MD, Principal investigator, University of Texas Health at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601571
- Sponsor's protocol ID
- HSC20200625H
- Status last verified
- May 2024
- First submitted
- 19 Oct 2020
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirming Feeding Tube Position Using the CORTRAK Enteral Access System
- ClinicalTrials.gov ID
- NCT04601571
- Acronym / sponsor ID
- HSC20200625H
- Conditions
- Enteral Nutrition
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Despite the study being in active enrollment since 2020, the research staff has not been available to enroll patients because of lack of trained nursing staff.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 23 Oct 2020 (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.
This study will compare the accuracy of the CORTRAK enteral access system (CEAS) to x-ray for the determination of feeding tube position within the abdomen.
Detailed description
In the inpatient pediatric care area (PICU, PCCU, PIMU, ACU), when an x-ray is performed for any reason and a patient has a CORTRAK feeding tube, a provider from the research team will re-insert the small, individualized, flexible stylet back into the patient's feeding tube and document the position of the tube on the CORTRAK display monitor. The x-ray will be obtained by current standard of care and the tube location on x-ray will be compared to the tube location on the CORTRAK monitor. The x-ray will only be obtained as part of the routine care decided by the medical team, the patient will not receive any additional x-rays for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A non-inferior cohort study design
| Arm | Type | Receives |
|---|---|---|
| Feeding Tube Placement using CORTRAK stylet | Active comparator | Device: CORTRAK StyletSubjects will already have a feeding tube placed and are undergoing X-rays for placement confirmation. |
| Feeding Tube Placement using X-Ray | No intervention | –Routine X-ray is used to confirm feeding tube placement |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- CORTRAK feeding tube placed as part of clinical care
- Getting xray for any reason
- CORTRAK Stylet available in the room
- Pediatric patients (Aged 17 or younger)
Key exclusion criteria (1 listed)
- -CORTRAK Stylet has been misplaced
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 |
|---|---|---|
| CORTRAK StyletAlso: Feeding tube styletThe stylet is a component of the CORTRAK feeding tube system used to confirm the correct placement of the feeding tube | Device | Feeding Tube Placement using CORTRAK stylet |
Primary outcome
Confirmation of correct placement of the Feeding tube
Time frame: Baseline to removal of feeding tube (on average 10-14 days)
An x-ray will be obtained first as per standard of care and within 4 hours of the x-ray, the research procedure will occur. Following slow and careful removal of the stylet, the research team member will ensure there has been no movement of the feeding tube per the depth indicators on the outside of the tube. The location of the tube as it appears on the CORTRAK monitor will be documented and the location of the tube on x-ray will be documented. This will be reported as number of times that the tube is correctly placed.
1 secondary outcome
Number of Radiographs required for placement
Time frame: Baseline to removal of feeding tube (on average 10-14 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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No DIET Trial: Dogmatic Interruption of Enteral nuTrition
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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. This study is not recruiting at the moment.
Andrew Meyer, MD principal investigator
University of Texas Health at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CORTRAK Stylet in people with Enteral Nutrition, run by The University of Texas Health Science Center at San Antonio 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 4 inclusion and 1 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: withdrawn, as of the sponsor's last update on 8 May 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmation of correct placement of the Feeding tube (time frame: Baseline to removal of feeding tube (on average 10-14 days)). 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 8 May 2024.