NCT04241146

Brief Summary

A randomized controlled trial comparing current standard blind method to CORTRAK enteral access system (CEAS), an FDA approved electromagnetic device to place enteric tubes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
29 days until next milestone

Results Posted

Study results publicly available

February 25, 2020

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

January 21, 2020

Results QC Date

January 25, 2020

Last Update Submit

February 13, 2020

Conditions

Enteral Feeding Intolerance

Keywords

enteral nutritionradiation exposurenursing carepediatricsradiation, non-ionizing

Outcome Measures

Primary Outcomes (1)

  • Duration of Time

    Time taken for placement of enteral tube

    Baseline to End of procedure up to 30 minutes

Secondary Outcomes (1)

  • Number of X-Rays

    Baseline to End of procedure up to 30 minutes

Study Arms (2)

Standard Blind Technique of Tube placement

ACTIVE COMPARATOR

FDA approved technique of enteral nutrition tube placement

Device: Enteric Tube

CORTRAK enteral access system (CEAS) placement

ACTIVE COMPARATOR

An electromagnetic device used to enable enteral nutrition tube placement

Device: CORTRAK enteral access system

Interventions

Enteric TubeDEVICE

A post pyloric feeding tube used in patients requiring enteral nutrition

Also known as: Enteral nutrition tube
Standard Blind Technique of Tube placement
CORTRAK enteral access systemDEVICE

Electromagnetic guidance system for enteric feeding tube placement

Also known as: CEAS
CORTRAK enteral access system (CEAS) placement

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

  • Jha P, Rupp L, Bonilla L, Gelfond J, Shah JN, Meyer AD. Electromagnetic Versus Blind Guidance of a Postpyloric Feeding Tube in Critically Ill Children. Pediatrics. 2020 Oct;146(4):e20193773. doi: 10.1542/peds.2019-3773.

    PMID: 32994178DERIVED

MeSH Terms

Interventions

Enteral Nutrition

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Results Point of Contact

Title
Prashant Jha
Organization
Children's Hospital of Nevada at UMC
prashant.jha@umcsn.com
702-383-2420

Study Officials

  • Andrew Meyer, MD

    University of Texas Health San Antonio

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Andrew Meyer, MD

Study Record Dates

First Submitted

January 21, 2020

First Posted

January 27, 2020

Study Start

January 6, 2018

Primary Completion

October 10, 2018

Study Completion

November 21, 2019

Last Updated

February 25, 2020

Results First Posted

February 25, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

De-identified data is available to all researchers upon contact of sponsoring organization and investigator Andrew D. Meyer.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available after primary manuscript is accepted for publication.
Access Criteria
Data will be available in journal publication

Locations

US(1)