Confirming Feeding Tube Position Using CORTRAK

NCT04601571 | Withdrawn DMC FDA Device

• 1 other identifier: HSC20200625H
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Enteral Nutrition

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to removal of feeding tube (on average 10-14 days)

Secondary Outcomes (1)

• Number of Radiographs required for placement

  Baseline to removal of feeding tube (on average 10-14 days)

Study Arms (2)

Feeding Tube Placement using CORTRAK stylet

ACTIVE COMPARATOR

Subjects will already have a feeding tube placed and are undergoing X-rays for placement confirmation.

Device: CORTRAK Stylet

Feeding Tube Placement using X-Ray

NO INTERVENTION

Routine X-ray is used to confirm feeding tube placement

Interventions

CORTRAK Stylet DEVICE

The stylet is a component of the CORTRAK feeding tube system used to confirm the correct placement of the feeding tube

Also known as: Feeding tube stylet

Feeding Tube Placement using CORTRAK stylet

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• CORTRAK Stylet has been misplaced

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University Health Systems Hospital

San Antonio, Texas, 78229, United States

Location

Study Officials

• Andrew Meyer, MD

  University of Texas Health at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A non-inferior cohort study design

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: March 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

US (1)