ARJ C13 Urea Breath Test System
Phase: PHASE2
Conditions: H. Pylori Infection
Sponsor: ARJ Medical, Inc.

Protocol Number: ARJ 2014-01
Confidential
ARJ Medical C13 Urea Breath Test Kit and Analyzer
Clinical Trial Protocol
ARJ Medical, Inc.
209 State Street East
Oldsmar, FL 34677
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Protocol Number: ARJ 2014-01
Confidential
ARJ MEDICAL,INC.
Clinical Trial Protocol
UREA C13
This confidential information about an investigational product is provided for the exclusive use of
investigators of this product and is subject to recall at any time. The information in this document
may not be disclosed unless federal or state law or regulations require such disclosure. Subject to the
foregoing, this information may be disclosed only to those persons involved in the study who have a
need to know, with the obligation not to further disseminate this information.
Protocol Number:
ARJ 2014-01
Version Date:
June 26,2015
Investigational Product:
ARJ C13 Urea Breath Test System
IND Number:
Development Phase:
Sponsor:
ARJ Medical,Inc.
209 State Street East
Oldsmar, FL34677
Funding Organization:
Gulf Coast Medical
Principal Investigator:
Name: 
 MD
Telephone: (  
 
Fax:
E-mail:
MedicalMonitor:
Name: 
, MD
Telephone: 
Fax:
E-mail:
Coordinating Center:
N/A
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[", 
Z0 v ?ptf
T

Protocol Number: ARJ 2014-01
PROTOCOL AGREEMENT
Confidential
I have read the protocol specified below. ln my formal capacity as Investigator, my duties
include ensuring the safety of the Study Subjects enrolled under my supervision and providing
ARI Medical, lnc. with complete and timely information, as outlined in the protocol. It is
understood that all information pertaining to the study will be held strictly confidential and that
this confidentiality requirement applies to all study staff at this site. Furthermore, on behalf of
the study staff and myself, I agree to maintain the procedures required to carry out the study in
accordance with accepted GCP principles and to abide by the terms of this protocol.
Protocol Number: ARJ 2014-01 Rev.6
Protocol Title: ARI C13 Urea Breath Test System
June
Inves ti gato r S ignatur e
Print
Site #
Site Name
Address
and Title
1
South Lake Gastroenterology
2040 Oakley Seaver Dr.
Clermont, FL 34711
Phone Number 
 
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Protocol Number: ARJ 2014-01
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TABLE OF CONTENTS
1 BACKGROUND
2 STUDY RATIONALE
2.1 Risk Benefit Assessment, 
...................10
3 STUDY OBJECTIVES
1l
3.t Primary Objective 
....'..'..11
3.2 Secondary Objectives... 
'........,...'..'."..1I
4 STUDY DESIGN
11
5 CRITERTA FOR EVALUATION
1l
5.1 Primary Efficacy Endpoint..... 
........'...1 I
5.2 Secondary Efficacy Endpoints 
...'.......12
5.3 Safety Evaluations. 
........'12
6 SUBJECTSELECTION
12
6.1 Study Population........... 
................'...'12
6.2 lnclusion Criteria........ 
."........'.'.."......12
6.3 Exclusion Criteria 
..........12
7 CONCURRENT MEDICATIONS 
12
7.1 Allowed Medications and Treatments............... 
..,......,...............12
8 STUDYTREATMENTS
13
8. I 
Method of Assigrring Subj ects to Treatment Groups .,...... 
....,.... I 3
8.2 Formulation of Test and Control Products,...,. 
.......13
8.3 Supply of Study Drug at the Site........ 
...............,....13
8.4 Supply of Study Drug at the Site.....,.. 
..............,.....14
8.5 Measures of Treatment Compliance................. 
..,....................,.14
STTIDY PROCEDURES AND GUIDELINES 
14
9.1 Clinical Assessments 
......14
9.2 Clinical Laboratory Measurements,.......,........ 
.......l5
EVALUATIONS BY VISIT 
15
10.1 Visit 1 Screening and Test (Day l) 
........................l5
10.2 Visit 2 - Study Test ............ 
................15
10,3 Early Withdrawal Visit.....,..... 
...........15
1I ADVERSE EXPERIENCE REPORTING AND DOCUMENTATION
16
I L I Adverse Events 
..........,...16
I 1.2 Serious Adverse Experiences (SAE).....,.... 
.,...,....,. 16
11.3 Medical Monitoring ................. 
..........17
12 DISCONTINUATION AND REPLACEMENT OF SUBJECTS
t7
l2.l Early Discontinuation of Study.,.... 
........................17
12.2 Replacement of Subjects.....,....... 
.......18
l0
10
l0
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Protocol Number: ARJ 2014-01
T3 PROTOCOL VIOLATIONS
14 STATISTICAL METHODS AND CONSIDERATIONS
Confidential
18
18
l4.l Data Sets Analyzed 
"""" 18
14.2 Demographic and Baseline Characteristics....'..,..'..... 
"""""""" l8
14.3 tnterimAnalysis..... 
""""18
14.4 Sample Size and Randomization,'.".'......'. 
""""""' 18
14.5 Data Collection lnstruments. 
""""""" 18
14.6 Data Management Procedures 
"""""" 19
14.7 DataQuality Control and ReportinC....'............ 
.."".."""""'"""' 19
14.8 Archival of Data.... 
.....".' 19
14.9 Availability and Retention of Investigational Records ..."."..'...'... 
."""""""' 19
14.10 Monitoring ........... 
""""" 19
14.11 Subject Confidentiality................ 
"""'20
15 ADMTNTSTRATM, ETHTCAL, REGULATORY CONSIDERATIONS 
20
15.1 Protocol Amendments...,.....,........ 
...'..20
15.2 Institutional Review Boards and Independent Ethics Committees 
....."..."....20
15.3 lnformed Consent Form........... 
.'......'.20
15.4 Publications.......... 
....'.....21
15.5 Investigator Responsibilities 
.........'....21
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Protocol Number: ARJ 2014-01
LIST OF ABBREVIATIONS
AE 
Adverse Event
CFR 
Code of Federal Regulations
CRF 
Case Report Form
DMC 
Data Monitoring Committee
DSMB 
Data Safety Monitoring Board
FDA 
Food and Drug Administration
GCP 
Good Clinical Practice
HIPAA 
Health Insurance Portability and Accountability Act of 1996
ICF 
lnformed Consent Form
ICH 
International Conference on Harmonisation
IEC 
Independent Ethics Commiffee
IRB 
Institutional Review Board
PI 
Principal lnvestigator
SAE 
Serious Adverse Experience
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Protocol Number: ARI 2014-01
Conlidential
PROTOCOL SYNOPSN
TITLE
ARI Cl3 Urea Breath Test: An Open-Label, Comparator Croup Study to Evaluate
the equivalency of the ARJ C13 Urea Breath Test System to the predicate device
ARI Pylo Plus.
SPONSOR
ARJ Medical, Inc.
T.UNDING
ORGANIZATTON
(iulf Coast Mcdical
NUMBER OF'SITES
3
RATIONALE
Patients who are experiencing the effects of gastritis, which is an inflammation,
iritation, or srosion of thc lining of lhe stomach rcquirc an identification of thc
status and gcneration ofurcasc in the stomach to providc a dchnitivc diagnosis.
Historically, this has been achieved via an upper endoscopy, whcre a thin tube
containing a tiny camcra, is inserted througlt your mouth and down into your
stomach to look at thc stolnach lining. The doctor will check for inflanttnation and
may pertbnn a biopsy, a proccdure in which a tiny sample of tissuc is removcd and
then sent to a laboratory for analysis.
By ingesting a low dosage of C13 urea, the patients'exhaled breath is then measured
to record thc lcvcl of change of llc labclc(l urca dcloctablc in a paticut's brcatir. 'I'his
is mcasurctl bcforc and attcr thc ingcstion ol'thc urea mixture. 'I'he cxhalcd brcatlt
is read by the analyzer whieh provides an immediate diagnoses and is non-invasive.
Although other Cl3 Urea Test Kits and analyzers are in the market, the ARJ Cl3
Breath Test System is believed to be equivalent in functionality and will be
manufactured in the U.S, which can provide a cost effective equivalent product.
STUDY DESIGN
Up to 3 centers, non-randomized, comparative study to compar€ the ARJ Cl3 Urea
Breath Test System to the ARJ Pylo Plus rapid urease test.
PRIMARY OBJECTIVE
To demonstrate the ARI C13 Breath Test System equivalency to the predicate ARJ
Pylo Plus rapid urease test.
SECONDARY
OBJECTIVES
None
NUMBER OF'SUBJtrCTS
Test Group: Approximately 100 - 300 Study Subjccts
SUBJECT SELECTION
CRITERIA
Inclusion Criteria:
r 
Male or Female Z 18 years of ago
r 
Patients who are experiencing the effects ofgasttitis
. 
Written informed consent (and assent when applicable) obtained frorn
subject and ability for subject to comply with the requirements of the study.
Exclusion Criteria:
r 
Pregnant or lactating female
. 
Study Subjects currently taking antibiotics
o Presence of a condition or abnormaliry that in the opinion of the
Investigator would compromise the safety of the patient or the quality of
the data
r 
Fasting required one hour prior to testing
. 
Study Subjects shall not consume the following items prior to the test
o Mouthwash
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Chewing gum
Carbonated beverages
Cigarette smoke
Ac-etone (to simulate the effect of ketone production that may result
from some diets)
Alcohol
o
o
o
o
o
TEST PRODUCT, DOSE,
AND ROUTE OF
ADMINISTRATION
ARJ Cl3 Breath Test System will be administered one time during a one-time visit
per study Subject, according to the standard procedure described in the device's
inrtn ctions. ihe administration shall be done orally followed by a series of
specifically timed exhalations of the subject's breath'
CONTROL PRODUCT,
DOSE AND ROUTE OF
ADMINISTRATION
The ARJ Pylo Plus comparator product will be administered once at a fbllow-up
appointment where the ARJ Pylo Plus test will be administered by the physician
uring u biopsy from the patient to test the presence ofh' Pylori'
DURATION OF SUBJECT
PARTICIPATION AND
DURATION OF STUDY
Subjects will be on studY for 2 daYs
Screening: up to 90 daYs
Test: 2 days
Reportingr 30 daYs
The total duration of the study is estimated to be 120 days. 3 months for subject
screening and testing lmonth for final analysis and reporting'
CONCOMITANT
MEDICATIONS
Allowed:
r 
No exclusions with the requirement of fasting one hour prior to testing
Prohibited:
r 
Antibiotics
EF['ICACY
EVALUATIONS
The efficacy cvaluations shall compare, per study subject, thc results of the ARI
C I 3 Breattr Test System to the results of the proven ARI Pylo Plus test- and the
biopsy histology, rapid urease and culture tests'
PRIMARY ENDPOINT
a
Results ofthe test study patients'breath tests demonstrate acceptance criterion
of > 957o,to the ARJ Pylo Plus test readings.
SECONDARY ENDPOINTS
Nonc
OTHER EVALUATIONS
None
SAFETY EVALUATIONS
When approximately 20oh of patients have completed the study, an interim analysis
for safety will bc conducted.
Serious Adverse Events will be monitored on an ongoing basis throughout the study'
PLANNED INTERIM
ANALYSES
when 20% of the study group patients have completed testing, analysis of thc study
results shall be processed and repeated monthly until the end of the study to cvaluate
the study progtession.
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STATISTICS
Primary Analysis PIan
Each review of the subject(s) shall be recorded including documentation of status at
selection and again during the comparative study test visit. The baseline reading and
each subsequent breath test shall provide a complete series ofbreath readings per
Study Subject. The analyzed breath readings shall be documented. The analysis of
the results shall be graphed for the Study Group. This is to illustrate progression
from start of the testing through the most recent day's tests of the study. At the end
of the study, thc results of the Study Croup's ARJ Cl3 Breath Test System shall be
compared to the results of the ARJ Pylo Plus, histology, rapid urease and culture
results as comparcd per study subject. The Study Group's results shall be calculated
and compared for equivalency.
Adverse Events shall be documented by subject. All identified Adverse Events shall
be given a level of adversity per Table 3- AE Severiry Grading. The analysis of the
results shall be graphed per subject and overall ofall subjects per study group. This
is to illustate adversity from start oftesting through the most rccent testing pcr
study group.
Rationale for Number of
Subjects
The clinical studies for the ARJ Cl3 Urea Breath Test predicate device Pylo-Plus
(K052708) included 100 study subjects.
The recent clearance (May 2013) of the Exalenz Bioscience Ltd. Breath ID Hp
System (K130524) included 79 pre-treatment study subjects.
The rationale to use approximately 100 - 300 study subjects shows equivalency to
the two (2) related clinical studies.
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1 BACKGROUND
Peptic ulcer disease is a cluonic inflammatory condition of the stomach and duodenum. Despite the fact that the
disease has relatively low mortality, it results in substantial suffering ofthose affected.
A shong association between H. pylori, chironic superficial gastritis and gaskointestinal disease has been well
established. H'pylori is associated with type B gastritis, duodenal ulcer, gastric ulcer, gastric cancer, and non-
Hodgkin's lymphoma.
H. pylori was first cultured successfully from human gastric mucosa in 1982. The organisms, spiral gram negative
bacteria, are found in the human stomach between the gastric epithelium and the rnuCosu. Isolates implicateJin the
above mentioned diseased states are distinguished by the production ofcopious amounts ofendogenous urea
amidohydrolase (urease). The enzyme catalyzes the breakdown of urea to iarbon dioxide and am-monia, which are
absorbed into the bloodstoeam.
Methods available for detecting current infection of the human stomach by H. pylori are generally divided into two
general types: Invasive and Non-invasive. Invasive methods are so called becauie they include, as a frst step, an
esophagogastroduodenoscopy ("EGD") with collection of gastric biopsies. These biopsies are then examined by
one or more detection methods: histological examination of stained tissue, microbiological culture of the organism,
or direct detection of urease activity in the tissue (for example, the CLOtest@). Biopsy based methods are
expensive, entail some patient risk and discomfort, and may give false negafive resulti du" to sampling errors when
colonization of the gastric mucosa is patchy.
The Cl3 Urea Breath Test kit is intended for use with the ARI Breath Test Analyzer, which is a combined product
referred to as the ARJ Cl3 Breath Test System for the qualitative detection of urease associated with Helicobacter
pylori as an aid in detecting H.pylori.
2 STUDY RATIONALE
Cashitis describes a group of conditions with one thing in common: inilammation of the lining of the stomach. The
inflammation of gashitis is most often the result of infection with the same bactsrium that cauics most stomach
ulcers, Injury, regular use of certain pain relievers and drinking too much alcohol also can contribute to gastritis
Flelicobacter pylori (l-1. pylori): A bacteria that livcs in the mucous lining of thc stornach; without trcatmcnt, the
inl'ection can lead to ulcers, and in sonre people, stomach cancer^
Patients who are experiencing the affects of gastritis, which is an inflammati6n, irritation, or erosion of the lining of
thc stomach require an identi tication of the status and generatiein of rrcase in the stomach to provide a tlefinitivc
diagnosis.
By.ingesting a low dosage ofCl3 urea, the patients'exhaled breath is then measured to record thc lcvcl olchangc
o[l]C labclcd urca dotcctable in a paticnt's brcath. I'his is mcasurcd belilre and alicr thc ingestion olrhe urea
ntixture. 'I'irc cxhaled brcath is read by the analyzer which provides an immediate diagnosis and is non-invasive.
Although other Cl3 Urea Test Kits and analyzers are in the market, the ARJ Cl3 Breith'Iest System is believed to
be equivalent in functionality and will be manufactured in the U.S. which can provide and cost effective equivalcnt
product.
2.1 Risk Benefit Assessment
2.1.1 Risk
F'or in vitro diagnostic use only. The l3C-urea powdcr and Citric Powder arc dissolvecl in a glass of
water and the rcsulting solution is takcn orally as part ofthe diagnostic proceduro. In thc case of
accidental overdose - drink water and call the physician.
A ncgative result docs not rule out the possibility of I"l. pylori inftction. F'alse negative rcsults can
occur with this procedure. lf clinical signs suggest I-I. pylori infbction, retcst with a ncw sample or an
alternatc method.
A falsc positive tcst ntay (rarely) occur duc to urease associatccl with othcr gastric spiral organisnts
observed in humans such as l{clicobactcr hcihnarmi.
A false positive test could occtu in patients who have achiorhydria.
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2.1.2
Benefit
. Noninvasive diagnosis ofIl. pylori.
r lligh dcgrcc oftcsting accuracy.
STUDY OBJECTIYES
3.1 Primary Objective
The primary objective is to assess the clinical efficacy of the ARJ Cl3 Breath Test System as compared to the ARI
pylo Plus test whictr tests the Study Subject's biopsy to determine the Study Subject's level of H.pylori.The results
oithe testing ofCl3 ureapresence in the Study Subjects'breath and read via the breath analyzers is compared to
the results of the ARI Pylo Plus test per study subject.
3.2 Secondary Objectives
None
STUDY DESIGN
4.1 Study Overview
This will be up to three sites, open label, comparative trial. Approximately 100 - 300 (number) of subjects are
planned. Each subject will be administered a single dose of study drug one time during a single visit. Evaluations
will be taken at baseline and at a specified time during the testing session'
Screening data will be reviewed to determine subject eligibility. Upon patient's consent, subjects who meet all
inclusion criteria and none of the exclusion criteria will be entered into the study.
The following testing regimens will be used:
. 
Using three independent sites, a total of 100-300 clinical samples are to be obtained from a population of
symptomatic individuals who have been prescribed endoscopic examination for the detection of H.Pylori
infection. The physician(s) will schedule test subjects per standard ofcare for an endoscopy procedure in
which a gastric mucosal biopsy will be obtained. In addition to the physician's standard testing, the
obtained tissue will also be used to perform the following tests:
o Histology
o Rapid Urease Test
o Culhue
r 
Experimental tre atment Azu C I 3 Urea Test dosage shall be a one-time dosage at time of initial testing.
. 
Comparator - ARJ Pylo Plus shall be a one-time test performed during a follow-up visit to examine the
study subject's biopsy to determine the level ofurease presence.
r 
Total duration of subject participation will be two visits. Total duration of the study is expected to be 4
months.
5 CRITERIA FOR EVALUATION
5.1 Primary Efficacy Endpoint
Upon the completion of the four (4) months of testing, the test results of ARJ Cl3 Urea are expected to
demonstrate equivalency to the ARJ Pylo Plus test results and equivalency to the results of the histology, rapid
urease and culture tests results.
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5.2 Secondary Efficacy Endpoints
The Study Subjects shall show no adverse conditions during the study. Ifadverse conditions are realized during the
study, the root cause analysis shall be performed and a determination shall be made as to the safety of the study
product.
5.3 Safety Evaluations
Incidence ofadverse events shall be addressed immediately and appropriate action shall be taken to ensure the
safety ofthe Study Subjects. Any advers€ event occrurences shall be aoalyzed and documentcd.
6 SUBJECT SELECTION
6.1 Study Population
Subjects with a potential diagnosis of peptic ulcer disease who meet the inclusion and exclusion criteria will be
eligible for participation in this study.
6.2 Inclusion Criteria
r 
Male or female >18 years of age at the time of the visit.
r 
Patients who are experiencing the effects ofgastritis.
r 
Written informed consent (and assent when applicable) obtained from subject and ability for subject to comply
with the requirements of the study.
6.3 Exclusion Criteria
. 
Pregnant or lactating women.
. 
Study Subjects currently taking antibiotics
r 
Presence of a condition or abnormalify that in the opinion of the Investigator would compromise the safety of
the patient or the quality of the data,
. 
Fasting required one hour prior to testing.
. 
Study Subjects shall not consume the following items prior to the test.
o Mouthwash
o Chewing gum
o Carbonated beverages
o Cigarette smoke
o Acetone (to simulate the effect of ketone production that may result from some diets)
o Alcohol
7 CONCI.]RRENTMEDICATIONS
All subjects should be maintained on the same medications through the individual's entire study period, as
medically I'easible, with no inhoduction of new chronic therapies.
7.1 Allowed Medications and Treatments
Standard therapy for gastritis is allowed except tbr keatments noted in the exclusion criteria described above and as
noted in the prohibited medications section below.
Prohibited Medications and Treatments
o The patient should have fasted at least one hour before administering the ARI Cl3 Breath Test System,
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STUDY TREATMENTS
8.1 Method of Assigning Subjects to Treatment Groups
Approximately 100 - 300 eligible patients will be assigned to the ARJ Cl3 Breath 1'est System.
8.2 Formulation of Test and Control Products
The study is to be performed the same across the entire population ofeach study group. Each Study Subject shall
be tested with the study product which is ARJ Cl3 Breath Test Kit. Each Study Subje;t shall be obr"*"d by th"
lnvestigator or designee during the testing. This is corlmon for all study subjects. 
-
8.2.1 Formulation of Test Product
ARJ Medical's C 13 Urea Test Kit consists of one sealed packet of premeasured Cl 3 urea, one packet of
premeasured citric acid and sweetener and two breath bags to bo used for the exhaled breath tobe measured. At the
time oftesting, the sealed packet ofpremeasured Cl3 urea shall be opened and the citric acid and sweetener shall
be added to the packet. The packet will then be filled with water andihe Study Subject shall drink the contents of
the packet until empty. see Table I for the formulation of ARI c13 Urea Test.
Table l: Formulation and Measurement
ARJ Cf 3 Urea Breath Test
l3C Urea
75 mg
Citric Acid F-lavoring Packet
Range ol 2-4 g
8.2.2 Formulation of Control Product
The ARJ Pylo Plus test is performed by evaluating a sample of the study subject's biopsy.
8.2.3 Packaging and Labeling
Study drug is supplied in single use kits.
Each carton (kit) of study drug will be labeled with the required FDA warning statement, the protocol number, a
treatment number, the name of the Sponsors, and directions for patient use and storage. Each-test kit will be
labeled with Protocol ID and Protocol Title and the statement "For investigational use only,':
8.3 Supply of Study Drug at the Site
The Study Sponsor (or designee) will deliver study product to the investigational site. The initial study product
delivery will be delivered after site activation (i.e., all required regulatory documentation has been reclived by the
Sponsor and a contract has been executed). Subsequent study product deliveries will be made after site requeit for
resupply.
8.3.1 Dosage/I)osageRegimen
The test subjects shall mix the urea and citric acid together in the provicled packet and fill the cpacket with water.
After mixing the contents of the packets the Study Subject shall ingest the packets liquid until the packet is empty.
8.3.2 Dispensing
The test subjects shall be prwided with the study product or the comparator product by the Investigator or designee
who shall administer the testing.
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8.3.3 Administrationlnstructions
Upon the Study Subject's initial arrival at the study site, the study Investigator shall provide the study subject with
their study record which includes their Study Subject identification and log into the study by entering:
o Study Subject ID (Name or Number)
e Date
The study Investigator or designee shall record the Study Subject's anival by documenting it on the Study Subjects'
Study Activity Form which will include:
r 
Study Subject's lD
e Date of Test
e Review ofcurrent health and health statistics
. 
Study Product ID Distributed to the Study Subject
r 
Consumption Time of Study Product
r 
Exhale Time and Analyzer Reading
. 
Review ofcurrent health and health statistics
o Adverse Events documentation
8.4 Supply of Study Drug at the Site
The study Sponsor shall supply the study product and comparator test product to the test site to ensure sufficient
quantities to maintain the testing without intemrption. The Sponsor and Investigator shall agrce on the minimum
quantrty of study product to be available on the premises of the study site to ensure availability of the study product
for the Study Subjects through the term ofthe study.
8.4.f Storage
ARJ C 1 3 Urea Test Systom shall be stored at room ternperature which would be approxirnately 25"C (77'F);
oxcursions pcrmitted to 15-30"C (59-86'F). The following colnponcnts ofthe test kits havc expiration dates:
the 13C-urca powcler and thc Citric Acid Powdcr. Do not use cither of thcsc components bcyond thc expiration datc
statcd on thc respectivc labels.
'fhe comparator product, ARJ Pylo Plus storage is at room tompcrature for up tri two (2) ycars. l)o not usc beyond
thc expiration datc.
8.5 Measures of Treatment Compliance
Subjects will be asked to log into the Study Subject Test Log by entering their respective Srudy Subject
Identification and date.
9 STUDY PROCEDURES AND GUIDELINES
A Schedule of Events representing the required testing procedures to be performed for the duration of the study is
diagrammed in Appendix l.
Prior to conducting any study-related activities, written informed consent and the Health lnsurance Portability and
Accountability Act (HIPAA) authorization must be signed and dated by the subject. If appropriate, assent must
also be obtained prior to conducting any study-related activities.
9.1 ClinicalAssessments
9.1.1 ConcomitantMedications
All concomitant medication and concurrent therapies will be documented at Baseline/Screening and at day of
testing. Dose, route, unit frequency of administration, and indication for administration and dates of medication
will be captured.
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9.1.2 Demographics
Demographic information (date of birth, gender, race) will be recorded at Screening.
9.1.3 Medical History
Relevant medical history, including history of current disease, other pertinent respiratory history, and information
regarding underlying diseases will be recorded at Screening.
9.1.4 PhysicalExamination
A complete physical examination will be performed by either the investigator or a sub-investigator who is a
physician at the subjecfs Screening. Qualified strff (MD, NP, RN, and PA) may complete the abbreviated
physical exam at day of Subject's testing. New abnormal physical exam findings must be documented and will be
reviewed with the physician prior to continuing with the Subjects test.
9.1.5 Vital Signs
Upon anival for the second testing, the body temperature, blood pressure, pulse and respirations will be performed
per physician typical protocol.
9.1.6 Adverse Events
Incidence ofAdverse Events shall be identified and documeuted by the Study Subject and also by the Investigator
during the testing and observation review. Any and all Adverse Events shall be documented in the Study Subjects'
testing log and also recorded and fiacked by the Investigator to be analyzed within the study statistics. Ifthe Study
Subject and/or the Investigator determine the Adverse Event was presonted by the use of the Cl3 Urea Test kit the
use of the study product shall be immediately terminated and necessary actions shall be taken to improve the Study
Subject's condition.
9.2 ClinicalLahoratory Measurements
None
10 EVALUATIONS BY VISIT
10.1 Visit 1 Screening and Test (Day 1)
l. Review the study with the subject and obtain written informed consent and HIPAA authorization and
assent, if appropriate.
2. Assiga the subject a unique screening number.
3. Record demographics data.
4. Record medical history, including a history of gastitis, diagnosis date, and prior gastritis treatments.
5. Record concomitant medications.
6. Perform and record vital signs.
7. Schedule subject for Visit 2 to perform study test (may be same day),
8. List all additional procedures, Dispense srudy drug (if same day)
10.2 Visit 2 - Study Test
l. Concomitant medications review (if not same day).
2. Perform and record vital signs.
10.3 Early Withdrawal Visit
l. Record any Adverse Experiences and/or for adverse experiences and exclusionary medication use.
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2. Record changes to concomitant medications.
3. Performand record vital signs.
II ADVERSE EXPERIENCE REPORTTNG AND DOCUMENTATION
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f 1.l Adverse Events
An adverse event (AE) is any untoward medical occurence in a clinical investigation of a patient administered a
pharmaceutical product and that does not necessarily have a causal relationship with the treatment. An AE is
therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease
temporally associated with the administration of an investigational product, whether or not related to that
investigational product. An unexpected AE is one ofa type not identified in nature, severity, or frequency in the
current Investigator's Brochure or ofgreater severity or frequency than expected based on the information in the
Investigator's Brochwe.
The Investigator will probe, via discussion with the subject, for the occurrence ofAEs during each subject visit and
record the information in the site's source documents. Adverse events will be recorded in the patient CRF.
Adverse events will be described by duration (start and stop dates and times), severity, outcome, trcatment and
relation to study drug, or if unrelated, the cause.
AE Severi$
The National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 should
be used to assess and grade AE severity, including laboratory abnormalities judged to be clinically significant. The
modified criteria can be found in the study manual. It should be pointed out that the term "seyere" is a measure of
intensity and that a severe AE is not necessarily serious.
AE Relationship to Study Drug
The relationship of an AE to the study drug should be assessed using the following the guidelines in Table 12.
Table 1. AE Relationship to Study Drug
11.2 Serious Adverse Experiences (SAE)
An SAE is defined as any AE occurring at any dose that results in any of the following outcomes:
r 
death
r 
a life-threatening adverse experience
o inpatient hospitalization or prolongation of existing hospitalization
Relationship
to Drug
Comment
Definitcly
Previously known toxicity of agent; or an evcnt that fbllows a reasonable tcmporal sequcncc
from administration of the drug; that follows a known or expccted response pattern to the
suspectcd drug; that is confirmed by stopping or reducing the dosagc of the drug; and that is
not explaincd by any other rcasonable hypothesis.
Probably
An cvcnt that follows a reasonablc temporal sequence from administration of the drug; that
tbllows a known or expected rc$ponse pattern to the suspected drug; that is confirmed try
stopping or reducing the dosage of the drug; and that is untikely to be explained by thc
known characteristics ofthe subject's clinical statc or by othcr intsrventions.
Possibly
An event that follows a reasonable temporal sequence from administration of the drug; that
follows a known or expected response pattern to that suspected drug; but that could readily
have been produced by a number ofother factors.
Unrelatcd
An cvcnt that can bc determined with certainty to have no rclationship to thc study drug.
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o 
a persistent or significant disability/incapacity
. 
a congenital anomaly/birth defect
Other important medical events may also be considered an SAE when, based on appropriate medical judgment,
they jeopardize the subject or require intervention to prevent one of the outcomes listed.
ll.2.l Serious Adverse Experience Reporting
The study site will document all SAEs that occur (whether or not related to study drug) per UCSF -ellR Guidelines.
The collection period for all SAEs will begin after informed consent is obtained and end after procedures for the
final study visit have been completed.
In accordance with the standard operating procedures and policies ofthe local Institutional Review Board
(IRB)ilndependent Ethics Committee (lEC), the site investigator will report SAEs to the IRB/IEC.
11.3 Medical Monitoring
 
 
, MD should be contacted directly at these numbers to report medical
concems or questions regarding safety.
Telephone: 
 
12 DISCONTINUATION AND REPLACEMENT OF SUBJECTS
l2.l Early Discontinuation of Study
A subject may be discontinued from study treatment at any time ifthe subject, the investigator, or tbe Sponsor feels
that it is not in the subject's best interest to continue. The following is a list of possible reasons for study troatment
discontinuation:
. 
Subject withdrawal ofconsent (or assent)
r 
Subject is not compliant with study procedures
. 
Adverse event that in the opinion ofthe investigator would be in the best interest ofthe subject to
discontinue study treatment
e Protocol violation requiring discontinuation of study treatment
r 
[,ost to follow-up
. 
Sponsor request for early termination of study
r 
Positive pregnancy test (females)
If a subject is withdrawn from treatment due to an adverse event, the subject will be followed and treated by the
Investigator until the abnormal parameter or symptom has resolved or stabilized.
All subjects who discontinue study treatment should come in for an early discontinuation visit as soon as possible
to ensure proper closure ofthe subject's participation in the study and to confirm the subject has no adverse
conditions.
All subjects are free to withdraw from participation at any time, for any reason, specified or unspecified, and
without prejudice.
Reasonable attempts will bq made by the investigator to provide a reason for subject withdrawals. The reason for
the subject's withdrawal from the study will be specified in the subject's source documents Refer to Section l0 for
early termination procedures.
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12.2 Replacement of Subjects
Subjects who withdraw from the study will be replaced.
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13 PROTOCOL VIOLATIONS
A protocol violation occurs when the subject, investigator, or Sponsor fails to adhere to significant protocol
requirements affecting the inclusion, exclusion, subject safety and primary endpoint criteria. Protocol violations
for this study include, but are not limited to, the following:
Failure to meet inclusion/exclusion criteria
Use of a prohibited concomitant medication
Failure to comply with Good Clinical Practice (GCP) guidelines will also result in a protocol violation. The
Sponsor will determine if a protocol violation will result in withdrawal of a subject.
When a protocol violation occlus, it will be discussed with the investigator and a Protocol Violation Form detailing
the violation will be generated. This form will be signed by a Sponsor representative and the Investigator. A copy
of the form will be filed in the site's regulatory binder and in the Sponsor's files.
14 STATISTICAL METHODS AND CONSIDERATIONS
Prior to the analysis of the final study data, a detailed Statistical Analysis Plan (SAP) will be written describing all
analyses that will be performed. The SAP will contain any modifications to the analysis plan described below.
14.1 Data Sets Analyzed
All eligible patients who are randomized into the study and receive at least one dose of the study drug (the Safety
Population) will be included in the safety analysis.
14.2 Demographic and Baseline Characteristics
The following demographic variables at screening will be summarized by: race, gender, age, height and weight.
14.3 Interim Analysis
Interim study analysis shall be performed after the initial two weeks of testing and again at the end of one month of
testing. Analysis will continue on a monthly basis until the end of the study.
14.4 Sample Size and Randomization
The sample size for this protocol was determined by:
The ARJ Cl3 Urea Breath Test predicate device Pylo-Plus (K052708) included 100 study subjects.
Thc recent clearance (May 2013) of the Exalenz Bioscience Ltd. BreathlD Hp System (Kl30524) included 79
study subjects.
The rationale to use approximately 100 * 300 study subjects shows equivalency to the 2 related clinical studies.
14.5 Data Collection Instruments
The Investigator will prepare and maintain adequate and accurate source documents designed to record all
observations and otherpertinent data for each subject treated with the study drug.
Study personnel at each site will enter data from source documents corresponding to a subject's visit into the
protocol-specific electronic Case Report Form (eCRF) OR paper CRF when the information corresponding to that
visit is available. Subjects will not be identified by name in the study database or on any study documents to be
collected by the Sponsor (or designee), but will be identified by a site number, subject number and initials.
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For eCRFs: If a conection is required for an eCM, the time and date stamps back the person entering or updating
eCRF data and creates an electronic audit trail. For paper CRFs; If a correction is made on a CRF, the study staff
member will line through the incorrect data, write in the correct data and initial and date the change.
The Investigator is responsible for all information collected on subjects enrolled in this study. dll data collected
during the course of this study must be reviewed and verified for completeness and accuacy by the Investigator. A
copy of the CRF will remain at the Investigator's site at the completion of the study.
14.6 Data Management Procedures
The data will be entered into a validated database. The Data Management group will be responsible for data
processing, in accordance with procedural documentation. Database lock will occur once quality assurance
procedures have been completed.
All procedures for the handling and analysis of data will be conducted using good computing practices meeting
FDA guidelines for the handling and analysis of data for clinical trials.
14.7 Data Quatity Control and Reporting
After data have been entered into the study database, a system of computerized data validation checks will be
implemented and applied to the database on a regular basis. For EDC studies: Queries are entered, ffacked, and
resolved through the EDC system directly. For paper studies; Query reports (Data Clarification Requests)
pertaining to data omissions and discrepancies will be forwarded to the Investigators and study monitors for
resolution. The study database will be updated in accordance with the resolved queries. All changes to the study
database will be documented.
14.8 Archival of Data
The database is safeguarded against unauthorized access by established security procedures; appropriate backup
copies of the database and related software files will be maintained. Databases are backed up by the database
administrator in conjunction with any updates or changes to the database.
At critical junctures of the protocol (e.g., production of interim reports and final reports), data for analysis is locksd
and cleaned per established procedures.
14.9 Availability and Retention of Investigational Records
The Investigator must make study data accessible to the monitor, other authorized representatives of the Sponsor
(or designee), IRB/IEC, and Regulatory Agency (e.g., FDA) inspectors upon request. A file for each subject must
be maintained that includes the signed Informed Consent, HIPAA Authorization and Assent Form and copies of all
source documentation related to that subject. The Investigator must ensure the reliability and availability of source
documents from which the information on the CRF was derived,
AII study documents (patient files, signed informed consent forms, copies of CRFs, Study File Notebook, etc.)
must be kept secured for a period of two years following marketing of the investigational product or for two years
after centers have been notified that the IND has been discontinued. There may be other circumstances for which
the Sponsor is required to maintain study records and, therefore, the Sponsor should be contacted prior to removing
study records for any reason.
l4.l0Monitoring
Monitoring visits will be conducted by representatives of the Sponsor according to the U.S. CFR Title 2l Parts 50,
56, and 312 and ICH Guidelines for GCP (E6). By signing this protocol, the Investigator grant$ permission to the
Sponsor (or designee), and appropriate regulatory authorities to conduct on-site monitoring and/or auditing ofall
appropriate study documentafion.
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14.1 I Subject Confidentiality
In order to maintain subject confidentiality, only a site number, subject number and subject initials will identify all
Study Subjects on CRFs and other documentation submitted to the Sponsor. Additional subject confidentiality
issues (if applicable) are covered in the Clinical Study Agreement.
15 ADMINISTRATIVE, ETHICAL, REGULATORY CONSIDERATIONS
The study will be conducted according to the Declaration of Helsinki, Protection of Human Volunteers (21 CFR
50), Institutional Review Boards (21 CFR 56), and Obligations of Clinical lnvcstigators (21 CFR 312).
To maintain confidentiality, all laboratory specimeus, evaluation forms, reports and other records will be identified
by a coded number and initials only, All study records will be kept in a locked file cabinet and code sheets linking
a patient's name to a patient identification number will be stored separately in another locked file cabinet. Clinical
information will not be released without written permission of the subject, except as necessary for monitoring by
the FDA. The Investigator must also comply with all applicable privacy regulations (e.g., tlealth lnsurance
Ponability and Accountability Act of 1996, EU Data Protection Directive 95l46lEC).
15.1 Protocol Amendments
Any amendment to the protocol will bs written by the Sponsor. Protocol amendments cannot be implcmented
without prior written IRB/IEC approval except as necessary to eliminate immediate safety hazards to patients. A
protocol amendment intended to eliminate an apparent immediate hazard to patients may be implemented
immediately, provided the IRBs are notified within five working days.
15.2 Institutional Review Boards and Independent Ethics Committees
The protocol and consent form will be reviewed and approved by the IRB/IEC of each participating center prior to
study initiation. Serious adverse experiences regardless ofcausality will be reported to the IRB/IEC in accordance
with the standard operating procedures and policies of the IRB/IEC, and the Investigator will keep the IRB/IEC
informed as to the progress of the study. The Investigator will obtain assurance of IRB/IEC compliance with
regulations.
Any documents that the IRBAEC may need to fulfill its responsibilities (such as protocol, protocol amendments,
Investigator's Brochure, coDsent forms, information concerning patient recruitment, payment or compensation
procedures, or other pertinent information) will be submitted to the IRB/IEC. The IRB/IECs written unconditional
approval ofthe study protocol and the informed consent form will be in the possession ofthe Investigator before
the study is initiated. The IRB/IECs unconditional approval statement will be hansmitted by the Investigator to the
Sponsor or designee prior to the shipment of study supplies to the site. This approval must refer to the study by
exact protocol titls and number and should identiff the documents reviewed and the date of review.
Protocol and/or informed consent modifications or changes may not be initiated without prior written IRBAEC
approval except when necessary to eliminate immediate hazards to the patients or when the change(s) involves only
logistical or administrative aspects of the study. Such modifications will be submitted to the IRB/IEC and wriuen
verification that thc modification was submitted and subsequently approved should be obtained.
The IRBAEC must be informed of revisions to other documents originally submitted for review; serious and/or
unoxpected advcrsc expericnoes oocurring during the study in accordance with the standard operating procedures
and policies of the IRB; new information that may affect adversely the safety of the patients of the conduct of the
study; an annual update and/or request for re-approval; and when the study has been completed.
15.3 Informed Consent f,'orm
Informed consent will be obtained in accordance with the US Code of Federal Regulations for Protection of Human
Subjects (21 CFR 50.25[a,b], CFR 50.27, and CFR Part 56, Subpart A), the Health Insurance Portability and
Accountability Act (HIPAA, if applicable), and local regulations.
The Investigator will prepare the informed consent form, assent and HIPAA authorization and provide the
documents to the Sponsor or designee for approval prior to submission to the IRB/IEC. The consent form
generated by the Investigator must be acceptable to the Sponsor and be approved by the IRB/IEC. The written
consent document will embody the elements of informed consent as described in the International Conference on
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Harmonisation and will also comply with local regulations. The Investigator will send an IRBAEC-approved copy
ofthe Informed Consent Form to the Sponsor (or designee) for the study file.
A properly exccuted, writtetr, informed consent will be obtained from each subject prior to entering the subjcct into
thc trial, Information should be given in both oral and written form and subjects must be given ample opporrunity
to inquire about details of the study. If appropriate and required by the local IRBIIEC, assent from the subject will
also be obtained. A copy ofthe signed consent form (and assent) will be given to the subject and the original will
be maintained with the subject's records.
15.4 Publications
The preparation and submittal for publication of manuscripts containing the study results shall be in accordance
with a process determined by mutual written agreement among the study Sponsor and participating institutions.
The publication or presentation of any study results shall comply with all applicable privacy laws, including, but
not limited to, the Health Insurance Portability and Accountability Act of 1996.
15.5 Investigator Responsibilities
By signing the Agreement of lnvestigator form, the Investigator agrces to:
r 
Conduct the study in accordance with the protocol and only make changes after notifuing the Sponsor (or
designee), except when to protect the safety, rights or welfare ofsubjects.
Personally conduct or supervise the study (or investigation).
Ensure that the requirements relating to obtaining informed consent and IRB review and approval meet federal
guidelines, as stated in $ 21 CFR, parts 50 and 56.
Report to the Sponsor or designee any AEs that occur in the course of thc study, in accordance with $21 CFR
312.64.
Ensure that all associates, colleagues and employees assisting in the conduct of the study are informed about their
obligations in meeting the above commitments.
Maintain adequate and accurate records in accordance with $21 CFR 312,62 and to make those records available
for inspection with the Sponsor (or designee).
Ensure that an IRB that complies with the requirements of $21 CFR part 56 will be responsible for initial and
continuing review and approval ofthe clinical study.
Promptly report to the IRB and the Sponsor (or designee) all changes in the research activity and all unanticipated
problems involving risks to subjects or others (to include amendments and IND safety reports).
Seek IRB approval before any changes are made in the research study, except when necessaxy to eliminate hazards
to the patients/subjects.
Comply with all other requirements regarding the obligations of clinical investigators and all other pertinent
requirements listed in $ 21 CFR part3l2.
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APPENDIX 1. EXAMPLE OF SCHEDULE OF STUDY VISITS
Vrsrr I
Selection/Breath Test
VISIT 2
TesUPylo Plus,
Histology, Rapid
Urease and Culture
Informed Conscnt
x
Medical History
x
Abbreviated Physical Exarn
x
Height
x
x
Weight
x
x
Vital Signs
x
x
Dispensing or Administration of
Study Drug
x
Counting of Returned Study llrug
x
Concomitant Mcdication Revicw
x
x
Adverse Expcriences
x
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