A Feasibility Study to Evaluate the Clinical Safety of ENvizion Medical™ Enteral Feeding Tube Placement Using the ENvizion Medical™ ENVUE™ System in Patients
Phase: NA
Conditions: Enteral Nutrition
Sponsor: Envizion Medical Ltd.

  
A FEASIBILITY STUDY TO EVALUATE THE CLINICAL SAFETY 
OF ENVIZION™ NASOENTERAL FEEDING TUBE 
PLACEMENT USING THE ENVIZION ™ ENVUE™ SYSTEM IN 
PATIENTS  
 
Protocol Number: NUTRI-002 
Principal Investigator: Dr. Lewis Jacobson 
Sponsor: ENvizion Medical Ltd. 
Version Number:  1.3 
July 11, 2018 
NCT Number: NCT03505593 
 
 
 
 
 
 
 

 
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STATEMENT OF COMPLIANCE 
Investigator Signature Page 
Study Title: 
A Feasibility Study to Evaluate the Clinical Safety of ENvizion™ Nasoenteral Feeding 
Tube Placement using the ENvizion™ ENVUE™ System in Patients (NUTRI-002) 
Investigational Devices: 
ENVUE System 
ENvizion™ NasoEnteral Tube 
Protocol Version: 
Version 1.3 
Protocol Date: 
July 11, 2018 
Sponsor: 
ENvizion Medical Ltd. 
Prior to participation in the clinical study (Protocol Number: NUTRI-002), as the Principal Investigator, I understand 
that I must obtain written approval from my Institutional Review Board (IRB). This approval must include my name, 
and I must send a copy to ENvizion (the COMPANY) or designee along with the IRB-approved Informed Consent 
Form (ICF) prior to study enrollment at my study site.  
As the Principal Investigator, I must also: 
1. Conduct the study in accordance with the study protocol, the signed Clinical Investigation Agreement, HIPAA 
requirements, IRB requirements and applicable FDA regulations (21 CFR Part 812, 50, 54 and 56) and ensure 
all study personnel are appropriately trained. 
2. Provide a copy of my curriculum vitae which includes my relevant professional experience including the dates, 
location, extent, and type of experience. 
3. Supervise all testing of the investigational device in this study. 
4. Ensure that the study has not commenced until IRB approval has been obtained. 
5. Immediately inform the COMPANY in writing if I become debarred from conducting clinical studies by FDA, or 
any professional organization (e.g., loss of medical license). 
6. Ensure that written informed consent is obtained from each patient prior to any study activities using the 
most recent IRB-approved Patient ICF. 
7. Provide all required data and reports and agree to source document verification of study data with patients’ 
medical records. 
8. Allow the COMPANY personnel or its designees, as well as FDA representatives, to inspect and copy 
documents pertaining to this investigation. 
9. Provide sufficient and accurate financial disclosure information and update information if any relevant 
changes occur during the investigation and for one year following the completion of the study. 
10. If involved in research that was terminated, I will provide an explanation in writing of the circumstances that 
led to the termination of the research. 
I have read and understand the contents of the Origin study protocol and agree to abide by the requirements set 
forth in this document. 
Dr. Lewis Jacobson 
St Vincent Indianapolis  
Investigator Name 
Investigative Site Name 
____________________________________ 
_________________________________ 
Investigator Signature 
Date 

 
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PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
STUDY TITLE 
A Feasibilty Study to Evaluate the Clinical Safety of ENvizion™ Nasoenteral Feeding Tube 
Placement using the ENvizion™ ENVUE System in Patients. 
PROTOCOL NUMBER 
NUTRI-002 
DEVICE DESCRIPTION 
The ENvizion™ ENVUE™ System is designed to aid qualified operators in the placement 
of the ENvizion™ NasoEnteral Tube™ of 10 Fr to 12 Fr into the stomach or small 
intestine of patients requiring enteral feeding.  The ENVUE System is intended as an 
adjunct to current placement practices for assisting clinical practitioners who place 
feeding tubes in adult patients.   
The ENvizion™ NasoEnteral Tube has been specifically designed for use with the 
ENVUE™ System and is intended for placement in the stomach or small intestine.  It is 
intended for use in adult patients who require intermittent or continuous feedings via 
the nasogastric or nasoenteric route. 
STUDY OBJECTIVES 
The objective of this study is to assess the safety of the ENVUE System as an adjunct to 
current practices for placement of nasoenteral feeding tubes.   
STUDY DESIGN 
The study is a prospective, single center, non-randomized clinical trial in patients that 
require placement of a nasoenteral feeding tube as a result of their current medical 
condition. 
NUMBER OF SUBJECTS 
AND SITES 
Up to fifty (50) subjects and at least forty (40) will complete the Procedure Visit 
(NasoEnteral Tube placement procedure, section 1.3) at a single center by at least five 
operators. This number (40-50 subjects) does not include screen failures.  ENvizion 
nasoenteral feeding tubes will be placed in 5 run-in subjects prior to enrollment of the 
remaining subjects. All enrolled subjects (run-in subjects and trial subjects) will be 
included in the final analysis. 
DURATION OF 
PARTICIPATION/STUDY 
Each patient’s individual participation will last approximately 20-48 hours. 
It is expected the entire study will take approximately two (2) months to complete. 
STUDY ENDPOINTS 
Primary Endpoint: 
Procedure success: Nasoenteral tube (NET) can be placed in the correct anatomical 
position without occurrence of guidance-related adverse events. 
 

 
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Additional Assessments: 
Procedure Metric s:  Number of placement attempts required 
Safety: Adverse Events 
SAMPLE SIZE 
CONSIDERATIONS 
There is no statistically based sample size for this study which is being conducted to 
obtain confirmatory evidence to support the safety of using the ENVUE System as an 
adjunct to current placement practices for nasoenteral feeding tubes. Forty (40) to Fifty 
(50) subjects (includes run-in subjects) completing the Procedure Visit (NasoEnteral 
Tube placement procedure) will provide evidence that the NET tube guidance system 
does not present new or different safety issues as compared to the predicate 
(confirmatory study). If less than 35 patients will complete the Follow-up Visit 
(confirmation of tube tip anatomical location), an enrollment of another 5 patients will 
be considered. 
SCHEDULED VISITS 
This study is an acute safety assessment of the ENVUE System covering the guidance 
functionality of the System.  
Screening 
The screening visit will occur at time zero and will assess eligibility for the study and 
obtain informed consent. 
Procedure 
The study procedure may occur within two days of screening.  Informed consent will be 
affirmed and the patient will be considered enrolled.  
Final Follow Up 
The final follow-up visit will occur 20-48 hours following the procedure. 
INCLUSION CRITERIA 
 
Patients must be >21 years of age 
 
Patients must require placement of a nasoenteral feeding tube 
 
Patients have an endotracheal tube, OR 
o 
Do not have an endotracheal tube but are sedated and/or classified as 
obtunded1 at the time of placement 
 
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 consent2 
                                                                
 
1 Obtundation level evaluation is based on Glasgow-Coma scale with a score of between 9 and 12. Sedation level is 
based on Richmond Agitation-Sedation Scale (RASS) score of -2 or less. 
2 Consent may be provided by patient’s legal authorized representative. 

 
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EXCLUSION CRITERIA 
 
Patients must not have a history of: 
o 
Esophageal varices or ulcers 
o 
Upper airway obstruction 
o 
Upper GI stenosis or obstruction 
o 
Trauma involving sinuses, nares face or neck that would prevent NG 
or oral tube insertion 
o 
Deformities of the sinus cavities and/or skull base 
o 
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 
STATISTICAL ANALYSIS  
All data will be reported using summary statistics. 
OTHER CONSIDERATIONS 
No core lab will be charted for this study; thus, judgements regarding placement will be 
based on the investigator’s assessment of X-Ray images.  Assessments of relatedness of 
any noted adverse events to the study device will be adjudicated by a Clinical Events 
Committee (CEC). No DSMB will be chartered for this study based on the well-
understood safety profile. 
US REGULATORY STATUS 
The ENVUE System is considered a non-significant risk investigational device in the 
United States.   
 
 

 
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1.2 
SCHEMA 
Figure 1: Study Flow Chart 
 
 
 
 
Screening
•Obtain informed consent
•Assess inclusion/exclusion criteria
•Capture baseline demographics, medical history and concomitant medications
•Collect clinical assessments (height, weight, previous X-Ray interpetation if available) 
Enrollment
•Affirmation of informed consent and enrollment (Only if screening visit is independent of procedure visit)
•ENvizion nasoenteral feeding tubes will be placed in 5 run-in subjects prior to enrollment of the remaining  
subjects
•Enroll the rest of the subjects
Procedure (within 2-days of screening)
•Collect pre-procedure vital signs
•Place NasoEnteral Tube using ENVUE System
•Collect procedure information (including number of tube replacement events)
•Confirm placement via X-Ray (within 5 hours)
•Assess for adverse events and device related side effects
Follow-up (20-48 hours post procedure)
•Collect vital signs
•Confirm tube location using ENVUE System and X-Ray
•Collect information regarding tube migration and reposition
•Assess for adverse events or device related side effects
Study Exit

 
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1.3 
SCHEDULE OF ACTIVITIES (SOA) 
The study schedule for this evaluation is presented below in Table 1. 
 
Table 1:  Study Schedule 
Procedures, Evaluations and 
Tests 
Study Visits 
Screening 
Procedure 
(Within 2 days of 
Screening Visit) 
Follow-up 
(20-48 hours after 
Procedure Visit) 
Informed Consent 
X 
X3 
 
Inclusion/Exclusion Criteria 
X 
 
 
Demographics 
X 
 
 
Medical History (Acute and Past) 
X 
 
 
Concomitant Medications4 
X 
 
 
Examinations 
 
Targeted Physical Exam
 
Vital Signs 
 
X 
 
 
 
X 
 
 
X 
ENvizionTM nasoenteral tube 
Placement 
 
X 
 
Confirm Anatomical Location 
 
ENVUE System 
 Abdominal and/ or thoracic X-
ray5 
 
 
 
X6 
 
X 
X 
Adverse Events 
 
X 
X 
 
 
 
                                                                
 
3 Affirmation of informed consent is only required if procedure visit is independent of screening visit. 
4 Limited to sedatives/any medication with sedative effect, anticoagulants and prokinetic agents. 
5 Additional X-Rays may be taken if clinically indicated. 
6 Within five hours of placement. 

 
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2 
STATISTICAL CONSIDERATIONS  
 
2.1 
STATISTICAL HYPOTHESES 
There is no formal statistical hypothesis for the primary endpoint of this feasibility trial.  The primary 
endpoint is defined as procedure success, e.g., NET tube can be placed in the correct anatomical 
position without occurrence of guidance-related adverse events. 
 
2.2 
SAMPLE SIZE DETERMINATION 
This feasibility trial will include forty (40) to fifty (50) patients completing the Procedure Visit 
(NasoEnteral Tube placement) and at least five operators.   ENvizion nasoenteral feeding tubes will be 
placed in 5 run-in subjects prior to enrollment of the remaining subjects. All enrolled subjects (run-in 
subjects and trial subjects) will be included in the final analysis. Patients or patients’ LAR who chose not 
to participate after informed consent but prior to procedure, and patients who because of system 
malfunction or because of undiscovered or unreported physical reasons (e.g. deteriorating health, 
anatomical anomalies, mechanical obstruction, etc.) cannot complete the Procedure Visit (NasoEnteral 
Tube placement) will be considered Screen Failures, not be considered in the total patient count, but 
will be reported in the ITT dataset as defined below. If less than 35 patients will complete the Follow-up 
Visit (confirmation of tube tip anatomical location), an enrollment of another 5 patients will be 
considered. 
 
2.3 
POPULATIONS FOR ANALYSES 
Populations that will be analyzed include the following: 
 
Intention-to-Treat (ITT) Analysis Dataset (i.e., all enrolled participants) 
 
Per-Protocol Analysis Dataset: defines enrolled patients for whom no protocol deviations were 
noted 
 
Full Cohort Dataset: includes the ITT population plus the Run-in patients 
 
2.4 
STATISTICAL ANALYSES 
The procedure success will be calculated for all populations. Additional descriptive statistics will be 
presented as appropriate using means, standard deviations, medians and ranges for the continuous 
variables and as counts and percentages for categorical variables.  
 
2.4.1 BASELINE DESCRIPTIVE STATISTICS 
Baseline demographics will be tabulated and include descriptive statistics were applicable. 
 
2.4.2 PLANNED INTERIM ANALYSES  
Interim analyses will not be conducted in this trial.   
2.4.3 SUB-GROUP ANALYSES 
There are no planned sub-group analyses.