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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04601571
Other study ID # HSC20200625H
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date March 2024
Est. completion date June 2026

Study information

Verified date May 2024
Source The University of Texas Health Science Center at San Antonio
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2026
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group N/A to 17 Years
Eligibility Inclusion Criteria: - 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) Exclusion Criteria: -CORTRAK Stylet has been misplaced

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University Health Systems Hospital San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of Radiographs required for placement Count of radiographs used to ensure correct placement of enteral feeding tube Baseline to removal of feeding tube (on average 10-14 days)
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