A Feasibility Study to Evaluate the Clinical Safety of Nutriseal™ Enteral Feeding Tube Placement Using the Nutriseal™ Nutriplace™ System in Patients
Phase: NA
Conditions: Enteral Nutrition
Sponsor: Nutriseal L.P

A FEASIBILITY STUDY TO EVALUATE THE CLINICAL SAFETY 
OF NUTRISEAL™ NASOENTERAL FEEDING TUBE 
PLACEMENT USING THE NUTRISEAL™ NUTRIPLACE™ 
SYSTEM IN PATIENTS  
 
Protocol Number: NUTRI-001 
Principal Investigator: Dr. May Olayan 
Sponsor: Nutriseal L.P. 
Version Number:  1.1 
February, 4 2018 
 
 

NUTRI-001 – v1.1      
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Summary of Changes from Previous Version: 
 
# 
Section 
Previous wording (Ver. 1.0) 
New wording (Ver. 1.1) 
Rationale for 
revision 
1. 1.1- 
Number of 
Subjects 
and Sites 
(Synopsis) 
Fifty (50) subjects will be 
enrolled at a single center by at 
least five operators.  Prior to 
participating in this trial each 
operator will place a Nutriseal 
nasoenteral feeding tubes in a 
run-in patient to provide 
training on the use of the 
NUTRIPLACE System. 
Fifty (50) subjects will  complete 
the Procedure Visit (NasoEnteral 
Tube placement procedure, 
section 1.3) at a single center by 
at least five operators. This 
number (50 subjects) does not 
include screen failures. Prior to 
participating in this trial each 
operator will place a Nutriseal 
nasoenteral feeding tubes in a 
run-in patient to provide training 
on the use of the NUTRIPLACE 
System. 
To clarify that the 50 
enrolled subjects will 
complete the 
Procedure Visit 
2. 1.1 Sample 
size 
consideratio
ns 
(Synopsis) 
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 
NUTRIPLACE System as an 
adjunct to current placement 
practices for nasoenteral 
feeding tubes. Fifty (50) patients 
will provide evidence that the 
NET tube guidance system does 
not present new or different 
safety issues as compared to the 
predicate (confirmatory study). 
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 
NUTRIPLACE System as an 
adjunct to current placement 
practices for nasoenteral feeding 
tubes. Fifty (50) patients  
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 
45 patients will complete the 
Follow-up Visit (confirmation of 
tube tip anatomical location, 
section 1.3), an enrollment of 
another 5 patients will be 
considered. 
To clarify sample size 
population 
3. 1.1 
Exclusion 
Criteria 
(Synopsis) 
 
5.2 
Exclusion 
Criteria 
(Study 
population) 
 
Upper airway obstruction 
 
Upper airway 
obstruction was 
added as an 
exclusion criteria - 
Such obstructions 
can prevent insertion 
of feeding tube 
 

NUTRI-001 – v1.1      
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4. 1.1 
Exclusion 
Criteria 
(Synopsis) 
 
5.2 
Exclusion 
Criteria 
(Study 
population) 
Gastrointestinal surgeries 
 
 
Gastrointestinal 
surgeries was 
omitted as an 
exclusion criteria- 
Not required as 
standard patient 
population may well 
have undergone 
Gastrointestinal 
surgery.  
Moreover, 
participation in the 
study of a subject 
who underwent a 
Gastrointestinal 
surgery should be 
per Investigator’s 
discretion as there is 
other exclusion 
criteria: “Patients 
must not have a 
significant 
concomitant illness 
that would adversely 
affect their 
participation in the 
study”. 
5. 1.1 
Exclusion 
Criteria 
(Synopsis) 
 
5.2 
Exclusion 
Criteria 
(Study 
population) 
Failed tube placement in the last 
seven days 
 
 
Failed tube 
placement in the last 
seven days was 
omitted as an 
exclusion criteria-  
Redundant as Chest 
X-Ray demonstrates 
if there is presence of 
any lung damage 
caused by a 
previously inserted 
feeding tube 
 
6. 5.4 Screen 
Failure 
Screen failures are defined as 
participants who consent to 
participate in the clinical trial 
but are not subsequently 
entered in the study. A minimal 
set of screen failure information 
is required to ensure 
transparent reporting of screen 
failure participants, to meet the 
Consolidated Standards of 
Reporting Trials (CONSORT) 
Screen failures are defined as 
participants who consent to 
participate in the clinical trial but 
are not subsequently entered in 
the study and do not complete 
the Procedure Visit. A minimal 
set of screen failure information 
is required to ensure 
transparent reporting of screen 
failure participants, to meet the 
Consolidated Standards of 
To clarify the 
definition of screen 
failures 

NUTRI-001 – v1.1      
iv 
publishing requirements and to 
respond to queries from 
regulatory authorities. Minimal 
information includes 
demography, screen failure 
details, eligibility criteria, and 
any serious adverse event (SAE). 
 
Reporting Trials (CONSORT) 
publishing requirements and to 
respond to queries from 
regulatory authorities. Minimal 
information includes 
demography, screen failure 
details, eligibility criteria, and 
any serious adverse event (SAE). 
7. 9.2 Sample 
Size 
Determinati
on 
This feasibility trial will include 
fifty (50) patients and five 
operators.  Each operator must 
complete training on one run-in 
subject prior to participating in 
this study.  
 
This feasibility trial will include 
fifty (50) patients completing the 
Procedure Visit (NasoEnteral 
Tube placement) and five 
operators.  Each operator must 
complete training on one run-in 
subject prior to participating in 
this study.  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 45 
patients will complete the 
Follow-up Visit (confirmation of 
tube tip anatomical location), an 
enrollment of another 5 patients 
will be considered. 
 
To clarify sample size 
population 

  
NUTRI-001 – v1.1      
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Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 1 
1 
PROTOCOL SUMMARY ............................................................................................................................... 2 
1.1 
Synopsis ................................................................................................................................................ 2 
1.2 
Schema ................................................................................................................................................. 5 
1.3 
Schedule of Activities (SoA) ............................................................................................................... 6 
2 
INTRODUCTION ............................................................................................................................................ 7 
2.1 
Study Rationale .................................................................................................................................... 7 
2.2 
Background........................................................................................................................................... 7 
2.3 
Risk/Benefit Assessment .................................................................................................................... 8 
2.3.1 
Known Potential Risks ..................................................................................................... 8 
2.3.2 
Known Potential Benefits ................................................................................................ 8 
2.3.3 
Assessment of Potential Risks and Benefits ................................................................ 8 
3 
OBJECTIVES AND ENDPOINTS ................................................................................................................ 9 
4 
STUDY DESIGN ............................................................................................................................................. 9 
4.1 
Overall Design ...................................................................................................................................... 9 
4.2 
End of Study Definition ....................................................................................................................... 9 
5 
STUDY POPULATION ................................................................................................................................ 10 
5.1 
Inclusion Criteria ................................................................................................................................ 10 
5.2 
Exclusion Criteria ............................................................................................................................... 10 
5.3 
Female patients who are pregnant or lactating ............................................................................. 10 
5.4 
Screen Failures .................................................................................................................................. 10 
5.5 
Strategies for Recruitment and Retention ...................................................................................... 11 
6 
STUDY INTERVENTION ............................................................................................................................ 12 
6.1 
Study Intervention(s) ......................................................................................................................... 12 
6.2 
Preparation/Handling/Storage/Accountability ................................................................................ 13 
6.2.1 
Acquisition and accountability ...................................................................................... 13 
6.2.2 
Product Storage and Stability ....................................................................................... 13 
6.2.3 
Preparation and use ...................................................................................................... 14 
6.3 
Measures to Minimize Bias: Randomization and Blinding ........................................................... 14 
6.4 
Concomitant Therapy ........................................................................................................................ 14 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL .................................................................................................................... 14 
7.1 
Participant Discontinuation/Withdrawal from the Study ............................................................... 14 
7.2 
Lost to Follow-Up ............................................................................................................................... 14 
8 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 14 
8.1 
Efficacy Assessments ....................................................................................................................... 14 
8.2 
Adverse Events and Serious Adverse Events ............................................................................... 15 
8.2.1 
Definition of Adverse Events (AE) ............................................................................... 15 
8.2.2 
Definition of Serious Adverse Events (SAE) .............................................................. 15 
8.2.3 
Classification of an Adverse Event .............................................................................. 15 
8.2.4 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 17 
8.2.5 
Adverse Event Reporting .............................................................................................. 17 
9 
STATISTICAL CONSIDERATIONS .......................................................................................................... 18 
9.1 
Statistical Hypotheses ....................................................................................................................... 18 
9.2 
Sample Size Determination .............................................................................................................. 18 

  
NUTRI-001 – v1.1      
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9.3 
Populations for Analyses .................................................................................................................. 18 
9.4 
Statistical Analyses............................................................................................................................ 18 
9.4.1 
Baseline Descriptive Statistics ..................................................................................... 18 
9.4.2 
Planned Interim Analyses ............................................................................................. 18 
9.4.3 
Sub-Group Analyses ..................................................................................................... 18 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 19 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 19 
10.1.1 
Informed Consent Process ........................................................................................... 19 
10.1.2 
Study Discontinuation and Closure ............................................................................. 19 
10.1.3 
Confidentiality and Privacy ........................................................................................... 19 
10.1.4 
Key Roles and Study Governance .............................................................................. 20 
10.1.5 
Safety Oversight ............................................................................................................. 20 
10.1.6 
Clinical Monitoring .......................................................................................................... 20 
10.1.7 
Quality Assurance and Quality Control ....................................................................... 21 
10.1.8 
Data Handling and Record Keeping ............................................................................ 21 
10.1.9 
Protocol Deviations ........................................................................................................ 21 
10.1.10 
Publication and Data Sharing Policy ........................................................................... 22 
10.1.11 
Conflict of Interest Policy .............................................................................................. 22 
10.2 
Abbreviations ...................................................................................................................................... 23 
10.3 
Protocol Amendment History ........................................................................................................... 24 
 
 
Attachment 1: 
Investigator’s Brochure 
Attachment 2: 
NUTRIPLACE System Instructions for Use 
Attachment 3: 
Nonsignificant Risk Justification 
Attachment 4: 
Proposed Informed Consent 
 

 
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STATEMENT OF COMPLIANCE 
Investigator Signature Page 
Study Title: 
A Feasibility Study to Evaluate the Clinical Safety of Nutriseal™ Nasoenteral Feeding 
Tube Placement using the Nutriseal™ NUTRIPLACE™ System in Patients (NUTRI-001) 
Investigational Devices: 
NUTRIPLACE System 
Nutriseal™ NasoEnteral Tube 
Protocol Version: 
Version 1.1 
Protocol Date: 
February, 4 2018 
Sponsor: 
Nutriseal L.P. 
Prior to participation in the clinical study (Protocol Number: NUTRI-001), 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 Nutriseal (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. May Olayan _______________________ 
Cleveland Clinic Foundation__________  
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 Nutriseal™ Nasoenteral Feeding 
Tube Placement using the Nutriseal™ NUTRIPLACE System in Patients. 
PROTOCOL NUMBER 
NUTRI-001 
DEVICE DESCRIPTION 
The Nutriseal™ NUTRIPLACE™ System is designed to aid qualified operators in the 
placement of the Nutriseal™ NasoEnteral Tube™ of 10 Fr to 12 Fr into the stomach or 
small intestine of patients requiring enteral feeding.  The NUTRIPLACE System is 
intended as an adjunct to current placement practices for assisting clinical practitioners 
who place feeding tubes in adult patients.   
The Nutriseal™ NasoEnteral Tube has been specifically designed for use with the 
NUTRIPLACE™ 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 NUTRIPLACE 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 
Fifty (50) subjects will complete the Procedure Visit (NasoEnteral Tube placement 
procedure, section 1.3) at a single center by at least five operators. This number (50 
subjects) does not include screen failures. Prior to participating in this trial each 
operator will place a Nutriseal nasoenteral feeding tubes in a run-in patient to provide 
training on the use of the NUTRIPLACE System. 
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. 
Additional Assessments: 

 
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Procedure Metrics:  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 NUTRIPLACE System as 
an adjunct to current placement practices for nasoenteral feeding tubes. Fifty (50) 
patients 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 45 patients 
will complete the Follow-up Visit (confirmation of tube tip anatomical location, section 
1.3), an enrollment of another 5 patients will be considered. 
SCHEDULED VISITS 
This study is an acute safety assessment of the NUTRIPLACE 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 
EXCLUSION CRITERIA 
• 
Patients must not have a history of: 
o 
Esophageal varices or ulcers 
o 
Upper airway obstruction 
o 
Upper GI stenosis or obstruction 
 
 
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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o 
Trauma involving sinuses, nares face or neck that would prevent NG 
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 NUTRIPLACE 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)
•One run-in subject per operator 
•Enroll Fifty (50) Patients
Procedure (within 2-days of screening)
•Collect pre-procedure vital signs
•Place NasoEnteral Tube using NUTRIPLACE 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 NUTRIPLACE 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 
NutrisealTM nasoenteral tube 
Placement 
 
X 
 
Confirm Anatomical Location 
 
NUTRIPLACE 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 
 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
This clinical study is designed to affirm the utility of the NUTRIPLACE System during placement of the 
Nutriseal nasoenteral feeding tubes. 
 
2.2 
BACKGROUND  
Enteral nutrition is the preferred route for the provision of nutritional support in most critical ill patients 
with functional gastrointestinal tract. The nasoenteric tube (NET) are easily placed at the bedside. Patients 
that most commonly require a NET are in the surgical, intensive care, neonatal and pediatric settings1,2. 
Enteral tube feeding is thought to preserve the integrity of the gut mucosa, and to reduce infectious 
complications. 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 savings3,4,5,6,7.  
It is estimated that approximately 1.2 million feeding tubes are placed blindly each year in the United 
States alone2,8,9,10,11. Despite the obvious advantages of the enteral tube feeding, inadvertent placement 
of NET 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 NET insertions, with 0.2 
to 1.2% of all the feeding tube placements cause pulmonary complications to patients3,12,13,14,15,9.  
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 placement3,16. 
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 position17. 
The NUTRIPLACE System is an electromagnetic tracking system which tracks the path of the feeding tube 
during placement.  The System utilizes an ElectroMagnetic (EM) sensor in the NET’s distal tip and a field 
generator as well as plate sensor (patient angle) and reference sensor (provides horizontal scaling of the 
body contour of the patient) and a Stylus which marks two anatomical landmarks (Xiphoid Process and 
Suprasternal Notch). 
The benefit of the system when NET is misdirected into the pulmonary system is a real-time visual tracing, 
which may prompt users to withdraw the tube and reinsert it. 
 
 

 
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2.3 
RISK/BENEFIT ASSESSMENT   
 
2.3.1 KNOWN POTENTIAL RISKS  
Risks associated with the placement and use of nasoenteral tubes include the following: 
• 
Placement in the lungs resulting in: 
o pneumothorax 
o pneumonia and sepsis 
• 
Irritation and coughing during placement 
• 
Damage to nasal ciliary epithelium leading to infection and/or sinusitis following long-term 
presence of an nasoenteral tube 
• 
Perforation of the esophagus in patients with esophageal varicies, ulcers, or history of cancer or 
neoplasms 
• 
Perforation of the base of the skull in patients with deformities of the skull base and/or sinus 
cavity 
• 
Reflux of stomach contents into the esophagus leading to aspiration 
• 
Parotitis 
• 
Minor bleeding during tube placement 
2.3.2 KNOWN POTENTIAL BENEFITS  
Potential benefits provided by the NUTRIPLACE System include improved placement accuracy for enteral 
feeding tubes, shorten time to confirm tube position, earlier enteral nutrition, immediate detection of 
tube misplacement and therefore reduced likelihood of incorrect tube placement, feeding into lungs and 
pneumothorax. The use of enteral feeding is intended for situations where such means are necessary to 
potentially save the patient’s life. 
 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
Taking into consideration all risks identified during analysis, and the benefits the NUTRIPLACE System 
provides to the patient, it has been determined to be an acceptable residual risk when weighed against 
the intended performance benefits. 
 
 

 
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3 
OBJECTIVES AND ENDPOINTS 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
 
 
The objective of this study is to 
assess the safety of the 
NUTRIPLACE System as an adjunct 
to current practices for placement 
of nasoenteral feeding tubes.  
Procedure success: NET tube can be 
placed in the correct anatomical 
position without occurrence of 
guidance-related adverse events.  
This endpoint will 
support the 
performance of the 
NUTRIPLACE System 
guidance. 
Secondary 
 
 
There are no secondary objectives for this trial 
Tertiary/Exploratory  
 
 
Procedure Metrics 
Number of placement attempts per 
patient. Tube migration. 
 
Safety 
Adverse Events 
 
 
 
4 
STUDY DESIGN  
 
4.1 
OVERALL DESIGN 
This is a single center, non-randomized feasibility clinical evaluation that is designed to affirm the safety 
of the NUTRIPLACE System guidance during the placement of the Nutriseal nasoenteral feeding tubes.  
Data collected during this trial is designed to ensure that NUTRIPLACE System can be used to successfully 
place Nutriseal NETs in the desired location without guidance-related adverse events. 
This study will be an in-hospital study which will follow enrolled subjects for an acute period of up to 48 
hours post-placement. 
 
4.2 
END OF STUDY DEFINITION 
The end of the study is defined as completion of the last visit or procedure shown in the SoA in the trial 
globally. 
 
 

 
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5 
STUDY POPULATION 
 
5.1 
INCLUSION CRITERIA 
Candidates for this study must meet the following inclusion criteria in order to be enrolled in this trial: 
• 
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 (RASS score of -2 or less) and/or 
obtunded (Glasgow Coma scale of9-12) 
• 
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 
5.2 
EXCLUSION CRITERIA 
Candidates for this study must not meet any of the following exclusionary criteria in order to be enrolled 
in this trial. 
• 
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 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 
5.3 
FEMALE PATIENTS WHO ARE PREGNANT OR LACTATING 
A urine pregnancy test will be required to rule out pregnancy in females of child-bearing potential. For 
female patients with a Foley catheter, urine samples for the pregnancy test are to be taken from the 
sample port on the catheter. 
 
5.4 
SCREEN FAILURES  
Screen failures are defined as participants who consent to participate in the clinical trial but are not 
subsequently entered in the study and do not complete the Procedure Visit. A minimal set of screen failure 
information is required to ensure transparent reporting of screen failure participants, to meet the 
Consolidated Standards of Reporting Trials (CONSORT) publishing requirements and to respond to queries 
from regulatory authorities. Minimal information includes demography, screen failure details, eligibility 
criteria, and any serious adverse event (SAE). 
 

 
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5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
Subjects for this trial will be recruited from the currently hospitalized and require placement of an NET 
tube.  It is anticipated that two months will be required to treat the run-in patients and enroll the full trial 
cohort.  Given the acute, in-hospital nature of this trial, no special measures will be needed to retain 
enrolled patients. 
 

 
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6 
STUDY INTERVENTION 
 
6.1 
STUDY INTERVENTION(S) 
The NUTRIPLACE System is composed of a dedicated mobile cart and is equipped with a battery-operated 
All-in-One (AIO) PC installed with the Microsoft™ Windows operating system.  The AIO PC runs the 
NUTRIPLACE software which controls the ElectroMagnetic (EM) tracking system which includes the field 
generator, marking stylus, and two patient (alignment) sensors.  The System also includes a printer, 
interface cables and a power cable for recharging the System batteries.  
 
The NUTRIPLACE System includes 9 major components: 
 
1. Plate sensor (patient-
position angle sensor)  
A thin, flat sensor positioned 
under the patient's upper back. 
 
 
5. Marking stylus  
A stylus equipped with a 
sensor and button, used to 
indicate the Suprasternal 
Notch and Xiphoid Process 
locations on the patient's 
chest.  
 
2. Reference sensor  
The reference sensor is placed 
on the side of the chest under 
the patient’s armpit. This sensor 
is used as a reference for EM 
tracking as well as to determine 
patient body width.  
 
 
6. Nasoenteral tube (NET) 
A feeding tube that is 
passed through the nose 
and down through the 
nasopharynx and 
esophagus into the 
stomach or post-pylorus. 
An EM sensor is embedded 
within the distal tip of the 
NET.  
 
3. Reference sensor patch  
A white plastic cover that is 
used to protect the reference 
sensor and to enable the 
attachment of the Reference 
sensor to the patient’s armpit. 
The reference sensor cover is 
single-use only and must be 
replaced for each patient. 
 
7. PC and touch screen 
A dedicated All-in-one 
computer running the 
Nutriplace software.  
 
 

 
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4. Field generator  
A rectangular electromagnetic-
field generator that is attached 
to the Nutriplace System. The 
field generator is placed above 
the patient’s chest.  
 
8. Nutriplace printer 
Used for printing final 
Placement report and 
screenshots 
 
9. Cart with handle 
A dedicated mobile 
cart housing the 
System 
components, 
containing drawers, 
wheels that can be 
locked and height 
adjustment pedal. 
 
 
 
 
A full description of the System and its use is provided in the Investigator’s Brochure (Attachment 1) the 
NUTRIPLACE System User Manual and the NasoEnteral Tube Instructions for Use (Attachment 2). The 
NUTRIPLACE System will be used on enrolled subjects following the documented methods and in 
consideration for the investigational sites standard of care regarding the placement of nasoenteral 
feeding tubes. 
The study of the NUTRIPLACE System is considered a non-significant risk study of an investigational 
medical device.  The rationale supporting the non-significant risk status is included in the NSR Letter 
(Attachment 3).   
 
6.2 
PREPARATION/HANDLING/STORAGE/ACCOUNTABILITY 
 
6.2.1 ACQUISITION AND ACCOUNTABILITY 
Sufficient supplies of the NUTRIPLACE System will be provided to the investigational site directly by 
manufacturer, Nutriseal L.P. 
 
6.2.2 PRODUCT STORAGE AND STABILITY 
The NUTRIPLACE System does not require special storage conditions, e.g., it may be stored at room 
temperature.  The Nutriseal NasoEnteral Tube should be stored in a clean dry location.  The shelf life for 
the product is stable for a minimum of 6 months. 
It is expected that the investigational site will store all components of the system in a secure location 
between uses. 
 

 
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6.2.3 PREPARATION AND USE 
Preparation and use of the NUTRIPLACE System are discussed in detail in the NUTRIPLACE System User 
manual and the NasoEnteral Tube Instructions for Use (Attachment 2). 
 
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
This is an open label, non-randomized feasibility trial with limited bias expected.  Bias in this study will be 
controlled through use of an independent CEC that will review and assess relatedness of reported adverse 
events to the NUTRIPLACE System. 
 
6.4 
CONCOMITANT THERAPY 
For this protocol, a prescription medication is defined as a medication that can be prescribed only by a 
properly authorized/licensed clinician. Medications to be reported in the Case Report Form (CRF) are 
concomitant prescription medications limited to sedatives/any medication with sedative effect, 
anticoagulants and prokinetic agents. 
 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
 
7.1 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
In the event a patient is discontinued from this study for any reason, all data will be collected through the 
time of discontinuation as well as the reason for discontinuation. 
 
7.2 
LOST TO FOLLOW-UP 
Given the acute, in hospital nature of this trial, follow-up loss of patients is not expected. 
 
8 
STUDY ASSESSMENTS AND PROCEDURES 
 
8.1 
EFFICACY ASSESSMENTS  
The following assessments will contribute to assessment of the NUTRIPLACE System: 
 
• 
Targeted Physical examination: height, weight 
• 
Vital signs: pulse, respiration, blood pressure, and oxygen saturation via pulse oximetry (Sp02)  
• 
Radiographic assessments: Abdominal and/or thoracic X-Ray will be required following the 
placement of the Nutriseal NasoEnteral Tube to confirm placement location and once during the 
follow-up period. 
• 
Number of Placement Attempts per Patient: 
o Replacement is defined as complete removal of the tube from the patient or retraction 
above the level of the pharynx followed by reinsertion 

 
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o Repositioning is defined as changing position of tube without complete removal of the 
tube 
• 
Tube Migration: Retrograde migration from desired placement position 
• 
Assessment of adverse events 
 
The specific timing of data collection is defined in section 1.3, Schedule of Activities. 
 
8.2 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
 
8.2.1 DEFINITION OF ADVERSE EVENTS (AE) 
An adverse event is defined as any untoward medical occurrence associated with the use of the 
NUTRIPLACE System whether or not the event is considered intervention-related. 
 
8.2.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE)  
An adverse event (AE) will be considered "serious" if, in the view of either the investigator or sponsor, it 
results in any of the following outcomes:  
 
• 
Death 
• 
A life-threatening adverse event 
• 
Inpatient hospitalization or prolongation of existing hospitalization 
• 
A persistent or significant incapacity or substantial disruption of the ability to conduct normal 
life functions 
• 
A congenital anomaly/birth defect 
• 
Other serious Important medical events that may not result in death, be life-threatening, or 
require hospitalization may be considered serious when, based upon appropriate medical 
judgment, they may jeopardize the participant and may require medical or surgical intervention 
to prevent one of the outcomes listed in this definition.  
An unanticipated adverse device effect (UADE) means any serious adverse effect on health or safety or 
any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or 
death was not previously identified in nature, severity, or degree of incidence in the clinical protocol, 
investigator’s brochure, or Instructions for Use (IFU) or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or welfare of subjects. 
 
8.2.3 CLASSIFICATION OF AN ADVERSE EVENT 
8.2.3.1 SEVERITY OF EVENT 
The investigator will categorize the severity of adverse events (AEs) reported in this study using the 
following definitions:  
 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
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• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating.  Of note, the term “severe” does not necessarily equate to “serious”. 
 
8.2.3.2 RELATIONSHIP TO STUDY INTERVENTION 
The investigator will categorize the relationship of all adverse events (AEs) reported in this study to the 
NUTRIPLACE System based on temporal relationship and his/her clinical judgment. The degree of certainty 
about causality will be graded using the categories below.  
 
• 
Definitely Related – There is clear evidence to suggest a causal relationship, and other possible 
contributing factors can be ruled out. 
• 
Probably Related – There is evidence to suggest a causal relationship, and the influence of other 
factors is unlikely. 
• 
Potentially Related – There is some evidence to suggest a causal relationship (e.g., the event 
occurred within a reasonable time after administration of the trial medication). However, other 
factors may have contributed to the event (e.g., the participant’s clinical condition, other 
concomitant events). 
• 
Unlikely to be related – A clinical event, including an abnormal laboratory test result, whose 
temporal relationship to study intervention administration makes a causal relationship 
improbable (e.g., the event did not occur within a reasonable time after administration of the 
study intervention) and in which other drugs or chemicals or underlying disease provides 
plausible explanations (e.g., the participant’s clinical condition, other concomitant treatments). 
• 
Not Related – The AE is completely independent of device and/or evidence exists that the event 
is definitely related to another etiology. There must be an alternative, definitive etiology 
documented by the clinician. 
In addition, AEs designated as “Definitely”, “Probably” or “Potentially” related to the NUTRIPLACE 
System will be further categorized by the investigator to determine the relationship of the event to the 
NUTRIPLACE Guidance System based on the following categories: 
 
• 
Events that likely resulted from insufficient information provided by the guidance system 
• 
Events that likely resulted from inaccurate or confusing information provided by the guidance 
system 
• 
Events that are not likely related to the guidance system. 
 
8.2.3.3 EXPECTEDNESS  
The investigator will be responsible for determining whether an adverse event (AE) is expected or 
unexpected.  An AE will be considered unexpected if the nature, severity, or frequency of the event is not 
consistent with the risk information previously described for the study intervention in the IB or the 
instructions for use. 
 

 
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8.2.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during study visits and interviews of a study participant or upon review by a study 
monitor. 
AEs not meeting the criteria for SAEs will be captured on the appropriate case report form (CRF). 
Information to be collected includes event description, time of onset, clinician’s assessment of severity, 
relationship to NUTRIPLACE System, and time of resolution/stabilization of the event. All AEs occurring 
while on study must be documented appropriately regardless of relationship. All SAEs determined to be 
related to the NUTRIPLACE System will be followed to adequate resolution or stabilization. 
Any medical condition that is present at the time that the participant is screened will be considered as 
baseline and not reported as an AE. However, if the study participant’s condition deteriorates at any time 
during the study, it will be recorded as an AE.  
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. AEs characterized as intermittent require documentation of 
onset and duration of each episode. 
 
8.2.5 ADVERSE EVENT REPORTING  
Any reported AE must be reported to Nutriseal via the CRF within 48 hours of the time the Investigator 
becomes aware of the AE. 
Any reported SAE must be reported to Nutriseal via the CRF within 24 hours of the time the Investigator 
becomes aware of the SAE. 
If the Investigator believes that a potential UADE has occurred, Nutriseal must be contacted immediately.  
In addition, the investigator shall submit to the Nutriseal and to the reviewing IRB a report of any 
unanticipated adverse device effect occurring during an investigation as soon as possible, but in no event 
later than 10 working days after the investigator first learns of the effect.”   
Nutriseal is responsible for conducting an evaluation of an unanticipated adverse device effect and shall 
report the results of such evaluation to the Food and Drug Administration (FDA) and to all reviewing IRBs 
and participating investigators within 10 working days after the sponsor first receives notice of the effect. 
Thereafter, the sponsor shall submit such additional reports concerning the effect as FDA requests. 
 
 

 
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9 
STATISTICAL CONSIDERATIONS  
 
9.1 
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. 
 
9.2 
SAMPLE SIZE DETERMINATION 
This feasibility trial will include fifty (50) patients completing the Procedure Visit (NasoEnteral Tube 
placement) and five operators.  Each operator must complete training on one run-in subject prior to 
participating in this study. 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 45 patients will complete the Follow-up Visit (confirmation of tube tip anatomical 
location), an enrollment of another 5 patients will be considered. 
 
9.3 
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 
 
9.4 
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.  
 
9.4.1 BASELINE DESCRIPTIVE STATISTICS 
Baseline demographics will be tabulated and include descriptive statistics were applicable. 
 
9.4.2 PLANNED INTERIM ANALYSES  
Interim analyses will not be conducted in this trial.   
 
9.4.3 SUB-GROUP ANALYSES 
There are no planned sub-group analyses. 

 
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10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
10.1.1 INFORMED CONSENT PROCESS 
 
10.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
 
Consent forms describing in detail the study intervention, study procedures, and risks are given to the 
participant and written documentation of informed consent is required prior to starting 
intervention/administering study intervention.  The consent materials contained in Attachment 4 are 
submitted with this protocol. 
 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the study 
and continues throughout the individual’s study participation. Consent forms will be Institutional Review 
Board (IRB)-approved and the participant or his/her legal authorized representative will be asked to read 
and review the document. The investigator will explain the research study to the participant or legal 
authorized representative and answer any questions that may arise. A verbal explanation will be provided 
in terms suited to the participant or legal authorized representative’s comprehension of the purposes, 
procedures, and potential risks of the study and of their rights as research participants.  Participants or 
legal authorized representatives will have the opportunity to carefully review the written consent form 
and ask questions prior to signing. The participant or legal authorized representative should have the 
opportunity to discuss the study with their family or surrogates or think about it prior to agreeing to 
participate. The participant or legal authorized representative will sign the informed consent document 
prior to any procedures being done specifically for the study. Participants or legal authorized 
representatives must be informed that participation is voluntary and that they may withdraw from the 
study at any time, without prejudice. A copy of the informed consent document will be given to the 
participants or legal authorized representatives for their records. The informed consent process will be 
conducted and documented in the source document (including the date), and the form signed, before the 
participant undergoes any study-specific procedures. The rights and welfare of the participants will be 
protected by emphasizing to them that the quality of their medical care will not be adversely affected if 
they decline to participate in this study. 
 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
Premature stoppage of this acute feasibility study is not anticipated given the planned enrollment and 
non-significant risk nature of this study. 
 
10.1.3 CONFIDENTIALITY AND PRIVACY  
Participant confidentiality and privacy is strictly held in trust by the participating investigator, their staff, 
and Nutriseal. Therefore, the study protocol, documentation, data, and all other information generated 

 
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will be held in strict confidence. No information concerning the study or the data will be released to any 
unauthorized third party without prior written approval of Nutriseal.  
The study monitor, other authorized representatives of Nutriseal, representatives of the Institutional 
Review Board (IRB), regulatory agencies may inspect all documents and records required to be maintained 
by the investigator, including but not limited to, medical records for the participants in this study. The 
clinical study site will permit access to such records. 
The study participant’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by the reviewing IRB, Institutional policies, or Nutriseal requirements. 
 
10.1.4 KEY ROLES AND STUDY GOVERNANCE 
Oversight of this clinical trial will be provided by: 
Principal Investigator 
May Olayan, M.D. 
Cleveland Clinic Foundation  
2049 East 100th Street 
Cleveland, OH 
Phone: 216-387-0182 
olayanm@ccf.org 
 
In addition, a Clinical Events Committee (CEC) will be convened to adjudicate adverse events reported in 
this trial.  Activities of the CEC will be governed by a CEC charter.   See description in 10.1.5 below. 
 
10.1.5 SAFETY OVERSIGHT 
A data safety monitoring board (DSMB) will not be convened for this non-significant risk study.  The CEC 
will consist of one physician and one engineer. Due to the expected short duration of this trial, the CEC 
will not provide interim analysis of data, but will instead review any SAE’s that occur to determine the 
need to halt the trial, and will adjudicate the involvement of the subject device in any AEs or SAEs.  Daily 
monitoring of the trial is being delegated to Dr. Anat Hofshi, an employee of NutriSeal.  This monitor will 
perform evaluation of the study conduct including informed consent, intake, execution, data recording, 
and reporting of AEs and SAEs.  Significant deviations from protocol will be immediately reported to the 
Sponsor and CEC.  Further, this monitor will notify the Sponsor and the CEC of any SAEs that occur and 
ensure all available data is provided to the CEC to evaluate whether the trial should continue. 
 
10.1.6 CLINICAL MONITORING 
Clinical site monitoring is conducted to ensure that the rights and well-being of trial participants are 
protected, that the reported trial data are accurate, complete, and verifiable, and that the conduct of the 
trial is in compliance with the currently approved protocol/amendment(s), with International Conference 
on Harmonisation Good Clinical Practice (ICH GCP), and with applicable regulatory requirement(s).  

 
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Nutriseal representative will conduct on-site monitoring.  Given the acute nature of this clinical trial, one 
visit is anticipated following the capture of all trial data.  During this visit, 100% source data verification 
will be confirmed.  
 
10.1.7 QUALITY ASSURANCE AND QUALITY CONTROL 
Following written Standard Operating Procedures (SOPs), the monitors will verify that the clinical trial is 
conducted and data are generated and biological specimens are collected, documented (recorded), and 
reported in compliance with the protocol, International Conference on Harmonisation Good Clinical 
Practice (ICH GCP), and applicable regulatory requirements (e.g., Good Laboratory Practices (GLP), Good 
Manufacturing Practices (GMP)).  
The investigational site will provide direct access to all trial related sites, source data/documents, and 
reports for the purpose of monitoring and auditing by the sponsor, and inspection by local and regulatory 
authorities. 
 
10.1.8 DATA HANDLING AND RECORD KEEPING  
 
10.1.8.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site 
investigator. The investigator is responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported. 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation of 
data. 
Hardcopies of the study visit worksheets will be provided for use as source document worksheets for 
recording data for each participant enrolled in the study.  Data recorded in the case report form (CRF) 
derived from source documents should be consistent with the data recorded on the source documents.  
 
10.1.8.2 STUDY RECORDS RETENTION  
Study documents should be retained for a minimum of 2 years after the last approval of a marketing 
application in an International Conference on Harmonization (ICH) region and until there are no pending 
or contemplated marketing applications in an ICH region or until at least 2 years have elapsed since the 
formal discontinuation of clinical development of the study intervention. These documents should be 
retained for a longer period, however, if required by local regulations. No records will be destroyed 
without the written consent of the sponsor, if applicable. It is the responsibility of the sponsor to inform 
the investigator when these documents no longer need to be retained. 
 
10.1.9 PROTOCOL DEVIATIONS  
A protocol deviation is any noncompliance with the clinical trial protocol, International Conference on 
Harmonization Good Clinical Practice (ICH GCP), or Manual of Procedures (MOP) requirements. The 
noncompliance may be either on the part of the participant, the investigator, or the study site staff. As a 
result of deviations, corrective actions are to be developed by the site and implemented promptly.  

 
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These practices are consistent with ICH GCP:  
• 
4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3  
• 
5.1 Quality Assurance and Quality Control, section 5.1.1  
• 
5.20 Noncompliance, sections 5.20.1, and 5.20.2.  
It is the responsibility of the site investigator to use continuous vigilance to identify and report deviations 
within five (5) working days of identification of the protocol deviation. All deviations must be addressed 
in study source documents and recorded in the appropriate CRF.  Protocol deviations must be sent to the 
reviewing Institutional Review Board (IRB) per their policies. The site investigator is responsible for 
knowing and adhering to the reviewing IRB requirements.  
 
10.1.10 
PUBLICATION AND DATA SHARING POLICY 
Twelve (12) months following the completion of the study, the Investigator may publish the result of their 
data from the study.  The Investigator shall provide the Nutriseal advanced copies of any proposed 
publication sixty (60) days prior to the planned publication.  Nutriseal will have sixty (60) days to review 
the proposed publication for the purposes described below. Nutriseal may request in writing (a) the 
deletion of any confidential information, (b) any reasonable changes requested, or (c) a delay of the 
proposed publication, not to exceed ninety (90) days, in order to protect the potential patentability of any 
technology. 
 
10.1.11 
CONFLICT OF INTEREST POLICY 
The independence of this study from any actual or perceived influence is critical.  Therefore, any actual 
conflict of interest of persons who have a role in the design, conduct, analysis, publication, or any aspect 
of this trial will be disclosed and managed. Furthermore, persons who have a perceived conflict of interest 
will be required to have such conflicts managed in a way that is appropriate to their participation in the 
design and conduct of this trial. The investigator and any sub-investigators are required to disclose the 
following financial interests, arrangements, and payments per 21 CFR 54.4(a)(3): 
 
• 
Any compensation made to the Investigator by Nutriseal of the covered clinical study in which 
the value of compensation could be affected by study outcome; 
• 
A proprietary interest in the tested product including, but not limited to, a patent, trademark, 
copyright, or licensing agreement; 
• 
Any equity interest in Nutriseal, i.e., any ownership interest, stock options, or other financial 
interest whose value cannot be readily determined through reference to public prices; 
• 
Any equity interest in Nutriseal if Nutriseal is a publicly held company and the interest exceeds 
$50,000 in value; and 
• 
Significant payments of other sorts made by Nutriseal to the Investigator of the Investigator’s 
institution, with a monetary value of $25,000 or more, during the time the Investigator is 
carrying out the study and for one (1) year following the completion of the study. 
 
 
 
 

 
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10.2 ABBREVIATIONS 
Abbreviation 
Definition 
AE 
Adverse Event 
AIO PC 
NUTRIPLACE all in one computer.  A substitute touch screen monitor may 
be used with a minimum size of 19 inch.   
Anatomical landmarks  
Two points on the patient's chest, one (upper) on the Suprasternal notch 
and the second on the Xiphoid process.  These are also referred to as 
fiducial points. 
Axial View 
A view of the body, observed from legs to head of the subject. 
CFR 
Code of Federal Regulations 
CONSORT 
Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
EM 
Electromagnetic 
EN 
Enteral Nutrition 
FDA 
Food and Drug Administration 
HIPAA 
Health Insurance Portability and Accountability Act  
IB 
Investigator’s Brochure 
ICH-GCP 
International Conference on Harmonization- Good Clinical Practice 
IFU 
Instruction For Use 
IRB 
Institutional Review Board 
ITT 
Intention-To-Treat 
Marking Stylus 
A Stylus equipped with a sensor, used to indicate the two anatomical 
landmarks (fiducial point) locations of the Suprasternal Notch and the 
Xiphoid Process 
NET 
The Nasoenteral Tube – Contains EM Sensor in the distal tip used with the 
NUTRIPLACE System.   The NET is a feeding tube that is passed through 
the nose and down the nasopharynx and esophagus into the stomach or 
small intestine and connected to a feeding pump or bag using an ENFit 
Connector 
NUTRIPLACE System 
The NUTRIPLACE System including all sensors and software.   
RASS 
Richmond Agitation-Sedation Scale 
SAE 
Serious Adverse Event 
SOA 
Schedule of Activities 
Software 
The NUTRIPLACE Software, running on the NUTRIPLACE PC 
SOP 
Standard Operating Procedure 
Suprasternal notch 
A large, visible notch in between the neck and the collarbone 
System 
The NUTRIPLACE System 
UADE 
Unanticipated Adverse Device Effects 
Xiphoid Process 
An extension of the lower part of the sternum. External anatomical 
indication for the entry to the stomach. 
 
 

 
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10.3 PROTOCOL AMENDMENT HISTORY 
The table below is intended to capture changes of IRB-approved versions of the protocol, including a 
description of the change and rationale. A Summary of Changes table for the current amendment is 
located in the Protocol Title Page.  
 
Version 
Date 
Description of Change  
Brief Rationale 
 
 
 
 
 
 
 
 
 

 
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feeding tube Placement complications. Ann Surg. 2011 Feb;253(2):287-302. 
3. David Smithard, Nicholas A. Barrett , et al. Electromagnetic Sensor-Guided Enteral Access 
Systems: A Literature Review. Dysphagia. 2015; 30(3): 275–285. 
4. Metheny NA. Preventing respiratory complications of tube feedings: evidence-based practice. Am 
J Crit Care. 2006 Jul;15(4):360-9. 
5. Powers J, et al. Bedside Placement of small-bowel feeding tubes in the intensive care unit. Crit 
Care Nurse. 2003 Feb;23(1):16-24. 
6. Taylor SJ, et al. Treating delayed gastric emptying in critical illness: metoclopramide, 
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2010 May-Jun;34(3):289-94. 
7. Gunnar Elke, et al. Enteral versus parenteral nutrition in critically ill patients: an updated 
systematic review and meta-analysis of randomized controlled trials. Crit Care. 2016; 20: 117. 
8. Metheny NA, Meert KL. Effectiveness of an electromagnetic feeding tube Placement device in 
detecting inadvertent respiratory Placement. Am J Crit Care. 2014 May;23(3):240-7. 
9. Krenitsky J. Nutrition issues in gastroenterology, series no. 93: blind bedside Placement of feeding 
tubes: treatment or threat? Pract Gastroenterol. 2011;35(3):32–42. 
10. Initial and Ongoing Verification of Feeding Tube Placement in Adults (applies to blind insertions 
and Placements with an electromagnetic device). Crit Care Nurse. 2016 Apr;36(2):e8-e13. 
11. Bryant V, Phang J, et al. Verifying Placement of small-bore feeding tubes: electromagnetic device 
images versus abdominal radiographs. Am J Crit Care. 2015 Nov;24(6):525-30. 
12. Arja Gerritsen, Marcel J. van der Poel, et al. Systematic review on bedside electromagnetic-
guided, endoscopic, and fluoroscopic Placement of nasoenteral feeding tubes. Gastrointestinal 
Endoscopy. 2015; 8(4): 836-847. 
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over traditional Placement technique? Nutr Clin Pract. 2007 Aug;22(4):436-44. 
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2011 Jul;35(4):535-9. 
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tubes in critical care. Am J Crit Care. 2013 Nov;22(6):521-7. 
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Placement Device in Detecting Respiratory Placements. Am J Crit Care. 2017 Mar;26(2):157-161. 
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a bedside electromagnetic technique. JPEN J Parenter Enteral Nutr. 25 (2001), p. 210 

 
Version 1.1 
NUTRI-001 
February, 4 2018 
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Attachment 1 
Investigator’s Brochure 
 
 

 
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NUTRI-001 
February, 4 2018 
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Attachment 2 
NUTRIPLACE System 
Instructions for Use 
 

 
Version 1.1 
NUTRI-001 
February, 4 2018 
3 
 
Attachment 3 
Nonsignficant Risk Justification 
 
 

 
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NUTRI-001 
February, 4 2018 
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Attachment 4 
Informed Consent