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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Enteral Nutrition

Intervention / Treatment
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* Device: ENVUE System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EFT placement using ENVUE System<br>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<br>* 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.<br>|

What is the study measuring?
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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) |