Feasibility Study to Evaluate Safety of ENvizion Medical™ ENVUE™ System

A Feasibility Study to Evaluate the Clinical Safety of ENvizion Medical™ Enteral Feeding Tube Placement Using the ENvizion Medical™ ENVUE™ System in Patients

This is a single center, non-randomized feasibility clinical evaluation that is designed to affirm the safety of the ENVUE™ System guidance during the placement of the ENvizion Medical™ enteral feeding tubes.

Study Overview

• Status: Completed
• Conditions: Enteral Nutrition
• Intervention / Treatment: Device: ENVUE System

Detailed Description

Enteral nutrition is the preferred route for the provision of nutritional support in most critical ill patients with functional gastrointestinal tract. Achieving early enteral nutrition (EN) in critically ill patients is associated with fewer major complications, reduced mortality and length of hospital stay, and significant cost savings. It is estimated that approximately 1.2 million feeding tubes are placed blindly each year in the United States alone. Despite the obvious advantages of the enteral tube feeding, inadvertent placement of Enteral Feeding Tube (EFT) into the airway is relatively common and can result in significant pulmonary injury including pneumothorax and pneumonia. Airway misplacement occurs in 1.2- 4 % of blind EFT insertions, with 0.2 to 1.2% of all the feeding tube placements cause pulmonary complications to patients. The gold standard for detecting inadvertent placement of a feeding tube in the lungs is radiography. However, because of its cost, possible delay of feedings while waiting for radiography, and risk for radiation exposure, clinicians continue to seek for alternative methods to confirm correct placement.

All the above mentioned, emphasizes the fact that safe and effective delivery of nasoenteral tube feedings requires assurance that the feeding tube tip is in a proper position. The ENVUE™ System is an electromagnetic tracking system which tracks the path of the feeding tube during placement. The benefit of the system when EFT is misdirected into the pulmonary system is a real-time visual tracing, which may prompt users to withdraw the tube and reinsert it.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • St.Vincent Hospital and Health Care Center, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients must be >21 years of age
• Patients must require placement of an enteral feeding tube
• Patients have an endotracheal tube, OR Do not have an endotracheal tube but are sedated (RASS score of -2 or less) and/or obtunded (Glasgow Coma scale of 9-12)
• Patients or legal authorized representative must be able to understand and adhere to all protocol procedures and be willing and able to provide written informed consent

Exclusion Criteria:

• Patients must not have a history of:

  • Esophageal varices or ulcers
  • Upper airway obstruction
  • Upper GI stenosis or obstruction
  • Trauma involving sinuses, nares face or neck that would prevent nasogastric (NG) or oral tube insertion
  • Deformities of the sinus cavities and/or skull base
  • Esophageal cancer or neoplasm
• Patients must not have a significant concomitant illness that would adversely affect their participation in the study
• Female patients who are pregnant or lactating

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EFT placement using ENVUE System; Placement of the ENvizion Medical™ Enteral Feeding Tube (EFT) in the stomach or small intestine of adult patients who require feedings via the oro/ nasoenteric route, using the ENVUE™ System.	Device: ENVUE System; The ENvizion Medical™ ENVUE™ System is designed to aid qualified operators in the placement of the ENvizion Medical™ Enteral Feeding Tube™ into the stomach or small intestine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Successfully Placed Enteral Feeding Tube	Enteral tube (EFT) can be placed in the correct anatomical position without occurrence of guidance-related adverse events. Procedure success was evaluated by comparing tube tip location according to the ENVUE System and abdominal and/or thoracic X-Ray. Guidance-related AEs were evaluated through the documentation of any guidance-related serious adverse events (SAE) or adverse events (AE) occurring during a subject's participation in the study.	During procedure visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Placement Attempts	Number of placement attempts was evaluated by number of replacement and repositioning events, as defined below: Replacement: Complete removal of the tube from the patient or retraction above the level of the pharynx followed by reinsertion; Repositioning: Changing position of tube without complete removal of the tube	During procedure visit
Number of Retrograde Tube Migration Events	Tube Migration was defined as: Retrograde migration from desired placement position.	During follow-up visit (20-48 hours post tube placement)

Collaborators and Investigators

• Sponsor: Envizion Medical Ltd.
• Investigators: Principal Investigator: Lewis Jacobson, MD, St.Vincent Hospital and Health Care Center, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2018
• Primary Completion (Actual): August 9, 2018
• Study Completion (Actual): August 9, 2018

Study Registration Dates

• First Submitted: April 9, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (Actual): April 23, 2018

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: August 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: NUTRI002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes