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Device

CORTRAK for Feeding Tube Placement Verification in Enteral Nutrition

N/A
Waitlist Available
Led By Andrew Meyer, MD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
CORTRAK feeding tube placed as part of clinical care
Pediatric patients (Aged 17 or younger)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to removal of feeding tube (on average 10-14 days)
Awards & highlights

Summary

This trial will compare how well two methods - the CORTRAK enteral access system and x-ray - work in determining the position of a feeding tube within the abdomen.

Who is the study for?
This trial is for pediatric patients (17 or younger) who are receiving enteral nutrition and need their feeding tube position confirmed. They must be getting an x-ray for any reason and have a CORTRAK Stylet available in the room. The study excludes those where the CORTRAK Stylet has been misplaced.Check my eligibility
What is being tested?
The study is testing how well the CORTRAK enteral access system can confirm the correct placement of feeding tubes in the abdomen compared to traditional x-ray methods.See study design
What are the potential side effects?
Since this trial involves comparing two methods of confirming tube placement rather than medication, there may not be direct side effects like with drugs; however, potential risks could include discomfort or complications from incorrect tube positioning.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a CORTRAK feeding tube installed.
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I am 17 years old or younger.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to removal of feeding tube (on average 10-14 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to removal of feeding tube (on average 10-14 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tube feeding of patient
Secondary outcome measures
Number of Radiographs required for placement

Trial Design

2Treatment groups
Active Control
Group I: Feeding Tube Placement using CORTRAK styletActive Control1 Intervention
Subjects will already have a feeding tube placed and are undergoing X-rays for placement confirmation.
Group II: Feeding Tube Placement using X-RayActive Control1 Intervention
Routine X-ray is used to confirm feeding tube placement

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Enteral nutrition involves delivering nutrients directly to the gastrointestinal tract, typically via a feeding tube. The most common treatments include the use of specialized formulas tailored to meet the nutritional needs of patients, and the precise placement of feeding tubes to ensure proper nutrient delivery and minimize complications. The CORTRAK enteral access system enhances this process by using electromagnetic tracking to provide real-time visualization of the feeding tube's position, reducing the risk of misplacement and associated complications such as aspiration or tube dislodgement. This technology is crucial for enteral nutrition patients as it ensures accurate and safe delivery of nutrition, which is essential for their recovery and overall health.

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
457 Previous Clinical Trials
91,601 Total Patients Enrolled
Andrew Meyer, MDPrincipal InvestigatorUniversity of Texas Health at San Antonio
1 Previous Clinical Trials
52 Total Patients Enrolled

Media Library

CORTRAK Stylet (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04601571 — N/A
Enteral Nutrition Research Study Groups: Feeding Tube Placement using CORTRAK stylet, Feeding Tube Placement using X-Ray
Enteral Nutrition Clinical Trial 2023: CORTRAK Stylet Highlights & Side Effects. Trial Name: NCT04601571 — N/A
CORTRAK Stylet (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04601571 — N/A
~0 spots leftby Jun 2025