Confirmatory Study to Assess the V Needle in End-Stage Renal Disease Patients During In-Clinic Hemodialysis: Clinic-SAVER
Phase: NA
Conditions: End Stage Renal Disease
Sponsor: Hemotek Medical Inc

Confirmatory Study to Assess the V Needle in End-Stage Renal Disease Patients During In-
Clinic Hemodialysis    
 
 
 
NCT05493423 
 
 
 
Date: April. 10, 2023 
 
 
Sponsor: Hemotek Medical Inc. 

     
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Confirmatory Study to Assess the V Needle in End-Stage 
Renal Disease Patients during In-Clinic Hemodialysis:  
Clinic-SAVER Study  
 
 
APPROVALS 
 
Charles Ventura:   
 
See Electronic Signature 
 
 
  Date:  
 
 
CEO, Hemotek Medical Inc. (Management Representative) 
 
Patrick Rousche:   
 
See Electronic Signature 
 
 
  Date:  
 
 
CSO, Hemotek Medical, Inc. (Product Development) 
 
Courtney Lane:   
 
                     
 
 
 
  Date:  
 
 
Clinical and Regulatory Consultant 
 
Heidi Hofacker:   
 
 
 
 
 
 
 
  Date:  
 
 
Clinical Representative, JMS North America 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

     
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1 
PROTOCOL SYNOPSIS .................................................................................................................................. 4 
1.1 
PROTOCOL SUMMARY ................................................................................................................................ 4 
1.2 
STUDY TITLE ................................................................................................................................................ 5 
1.3 
STUDY DESCRIPTION: .................................................................................................................................. 5 
1.4 
STUDY OBJECTIVES ..................................................................................................................................... 5 
1.5 
CLINICAL PHASE .......................................................................................................................................... 5 
1.6 
INDICATIONS FOR USE ................................................................................................................................ 5 
1.7 
STUDY DEVICE ............................................................................................................................................. 5 
1.8 
STUDY RATIONALE ...................................................................................................................................... 6 
1.9 
STUDY POPULATION ................................................................................................................................... 6 
1.10 
CLINICAL SITES ............................................................................................................................................ 6 
1.11 
NUMBER OF SUBJECTS ............................................................................................................................... 6 
1.12 
STUDY DURATION ....................................................................................................................................... 6 
1.13 
INCLUSION CRITERIA .................................................................................................................................. 7 
1.14 
EXCLUSION CRITERIA .................................................................................................................................. 7 
1.15 
PRIMARY SAFETY MEASURE ....................................................................................................................... 7 
1.16 
ADDITIONAL SAFETY MEASURES ................................................................................................................ 7 
1.17 
PRIMARY PERFORMANCE MEASURES ........................................................................................................ 8 
1.18 
SECONDARY PERFORMANCE MEASURES ................................................................................................... 8 
1.19 
ADDITIONAL PERFORMANCE MEASURES ................................................................................................... 8 
1.20 
STUDY DESIGN ............................................................................................................................................ 8 
1.21 
SAMPLE SIZE JUSTIFICATION ....................................................................................................................... 9 
1.22 
STUDY TIMELINE ....................................................................................................................................... 10 
1.23 
SCHEDULE OF ACTIVITIES (SOA) ................................................................................................................ 11 
1.24 
STUDY PARTICIPANT DURATION ............................................................................................................... 11 
2 
STATEMENT OF COMPLIANCE ................................................................................................................... 12 
3 
INTRODUCTION ........................................................................................................................................ 13 
3.1 
STUDY RATIONALE ......................................................................................................................................... 13 
3.2 
BACKGROUND .............................................................................................................................................. 13 
3.3 
RISK/BENEFIT ASSESSMENT ............................................................................................................................. 14 
4 
OBJECTIVES AND ENDPOINTS .................................................................................................................... 15 
4.1 
PRIMARY SAFETY MEASURE ..................................................................................................................... 15 
4.2 
ADDITIONAL SAFETY MEASURES .............................................................................................................. 15 
4.3 
PRIMARY PERFORMANCE MEASURES ...................................................................................................... 15 
4.4 
ADDITIONAL PERFORMANCE MEASURES ................................................................................................. 15 
5 
STUDY DESIGN .......................................................................................................................................... 16 
5.1 
OVERALL DESIGN .......................................................................................................................................... 16 
5.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN ......................................................................................................... 16 
5.3 
END OF STUDY DEFINITION ............................................................................................................................. 17 
6 
STUDY POPULATION ................................................................................................................................. 17 
6.1 
INCLUSION CRITERIA ...................................................................................................................................... 17 
6.2 
EXCLUSION CRITERIA ...................................................................................................................................... 18 
6.3 
SCREEN FAILURES .......................................................................................................................................... 18 
6.4 
STRATEGIES FOR RECRUITMENT AND RETENTION ................................................................................................. 18 
7 
STUDY INTERVENTION .............................................................................................................................. 19 
7.1 
STUDY INTERVENTION(S) ADMINISTRATION ........................................................................................................ 19 
7.2 
PREPARATION/HANDLING/STORAGE/ACCOUNTABILITY ........................................................................................ 19 
7.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING ........................................................................... 19 
7.4 
STUDY INTERVENTION COMPLIANCE .................................................................................................................. 20 
8 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT DISCONTINUATION/WITHDRAWAL ........... 20 
8.1 
DISCONTINUATION OF STUDY INTERVENTION ...................................................................................................... 20 
8.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY ......................................................................... 20 

     
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8.3 
LOST TO FOLLOW-UP ..................................................................................................................................... 20 
9 
STUDY ASSESSMENTS AND PROCEDURES .................................................................................................. 21 
9.1 
EFFICACY ASSESSMENTS ................................................................................................................................. 21 
9.2 
SAFETY AND OTHER ASSESSMENTS ................................................................................................................... 23 
10 
STATISTICAL CONSIDERATIONS ................................................................................................................. 28 
10.1 
STATISTICAL HYPOTHESES ............................................................................................................................... 28 
10.2 
POPULATIONS FOR ANALYSES .......................................................................................................................... 30 
10.3 
STATISTICAL ANALYSES ................................................................................................................................... 30 
10.4 
OTHER STATISICAL CONSIDERATIONS ................................................................................................................. 31 
11 
REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS ......................................................... 32 
11.1 
INFORMED CONSENT PROCESS ......................................................................................................................... 32 
11.2 
STUDY DISCONTINUATION AND CLOSURE ........................................................................................................... 32 
11.3 
CONFIDENTIALITY AND PRIVACY ....................................................................................................................... 33 
11.4 
FUTURE USE OF STORED SPECIMENS AND DATA .................................................................................................. 33 
11.5 
SAFETY OVERSIGHT ........................................................................................................................................ 33 
11.6 
CLINICAL MONITORING .................................................................................................................................. 34 
11.7 
QUALITY ASSURANCE AND QUALITY CONTROL .................................................................................................... 34 
11.8 
DATA HANDLING AND RECORD KEEPING ............................................................................................................ 34 
11.9 
PROTOCOL DEVIATIONS .................................................................................................................................. 35 
11.10 
PUBLICATION AND DATA SHARING POLICY .......................................................................................................... 35 
11.11 
CONFLICT OF INTEREST POLICY ......................................................................................................................... 36 
12 
ABBREVIATIONS ....................................................................................................................................... 36 
REVISION HISTORY ............................................................................................................................................. 37 
 
 
 

     
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Clinic-SAVER Study 
1 Protocol Synopsis 
1.1 
PROTOCOL SUMMARY 
In patients undergoing hemodialysis for the treatment of end-stage renal disease, Venous Needle 
Dislodgement (VND) is a rare, but potentially fatal situation in which the needle delivering a 
patient’s blood back to the body after filtration by a dialysis machine becomes inadvertently 
disconnected from the patient. Hemotek Medical Inc. has developed the V Needle, a venous 
needle return that is designed to reduce patient risk from exsanguination-related injury or death. 
This clinical study will serve as a confirmatory study to gain FDA marketing clearance of the 
Hemotek V Needle system in the clinical setting. During this study, we will determine the ability 
of the V Needle to successfully deliver appropriate hemodialysis therapy per the facility’s 
guidelines.  It will also be used to determine if the V Needle triggers false blood alarms under 
normal operating conditions. This study will also be used to demonstrate the V Needle meets 
effective usability criteria. Rates of adverse events and ability to complete the hemodialysis 
session will be compared to the rates recorded using commercially available devices during the 
hemodialysis sessions prior to the use of the Hemotek V Needle. 
This study is a prospective, multi-center, single-arm study with subjects acting as their own 
control designed to confirm the safety, performance, and usability of the V Needle, a new safety 
needle for use during in-clinic hemodialysis that is designed to automatically generate a partial 
occlusion of the internal fluid path and trigger the hemodialysis machine to alarm and shut off if a 
complete dislodgement of the venous needle from the arm inadvertently occurs.  
The study is an open-label, non-randomized, single arm, multi-center trial with subject’s serving 
as their own control. For the first three (3) control sessions, subjects will undergo usual 
hemodialysis sessions with a commercially available device.  For the remaining six (6) sessions, 
subjects will be cannulated with a V Needle in place of a usual venous line AV fistula set.   
The hemodialysis sessions will be conducted in the clinic. Subjects will be observed by a 
clinician for the duration of each session. Clinicians will monitor the session for any abnormal 
disruptions, therapy interruptions, and/or adverse events, including hemolysis, due to V Needle 
presence. All machine blood alarms, therapy interruptions, and/or partial or complete needle 
dislodgements will be recorded and immediately corrected. A clinician will perform cannulation. 
Cannulation site and surrounding tissue will be examined by the nurse and assessed for any 
locally induced trauma before and after treatment.  
A survey will be completed by the clinicians and patients to assess usability, comfort, and 
feelings of safety of the V Needle. 
After the first five (5) patients will be enrolled, and data through the last visit of the fifth patient 
is available, this data will be submitted to the FDA while study enrollment and visits continue. 
No Hemotek Medical V Needle treatments will occur until after FDA has reviewed the data from 
the first 5 patients and allows the study to proceed. Data will also be submitted to the FDA after 
the tenth patient completes their last visit and data is available. After the tenth patient, study 

     
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enrollment and visits can continue, but no Hemotek Medical V Needle treatments will occur on 
the final 5-10 patients until the FDA allows the study to proceed.  After FDA has found the data 
for the first 10 patients acceptable, the rest of the study can continue until the end. 
 
1.2 
STUDY TITLE 
Confirmatory Study to Assess the V Needle in End-Stage Renal Disease Patients during in-clinic 
hemodialysis: Clinic-SAVER Study 
1.3 
STUDY DESCRIPTION: 
This study is a prospective, multi-center, single-arm study with subjects acting as their own 
control designed to confirm the safety, performance, and usability of the V Needle, a new safety 
needle for use during in-clinic hemodialysis that is designed to automatically generate a partial 
occlusion of the internal fluid path and trigger the hemodialysis machine to alarm and shut off if a 
complete dislodgement of the venous needle from the arm inadvertently occurs. 
1.4 
STUDY OBJECTIVES 
The study is designed to confirm the safety, performance, and usability of the Hemotek V Needle 
A.V. Fistula Set for temporary cannulation for hemodialysis in the treatment of end-stage renal 
disease patients in the clinical setting. 
1.5 
CLINICAL PHASE 
This study is a confirmatory study designed to provide clinical evidence for use in obtaining 
marketing clearance, i.e. 510(k) clearance, for the Hemotek device. 
1.6 
INDICATIONS FOR USE 
The Hemotek V Needle A.V. Fistula Set is intended for temporary cannulation to vascular access 
for extracorporeal blood treatment for hemodialysis. This device is intended for single use only. 
The anti-needlestick safety feature aids in prevention of needle stick injuries when removing and 
discarding the needle after dialysis. The device also has an integrated safety mechanism that is 
designed to automatically generate a partial occlusion of the internal fluid path and trigger the 
hemodialysis machine to alarm and shut off if a complete dislodgement of the venous needle 
from the arm inadvertently occurs. 
1.7 
STUDY DEVICE 
The Hemotek V Needle A.V. Fistula Set is a set that includes a needle used to access the 
vasculature during hemodialysis. The V Needle incorporates both a detection system that is 
designed to detect when the venous needle becomes completely dislodged from the patient’s arm 

     
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and an internal mechanism that is designed to occlude the flow of blood through the needle in the 
dislodged state. The induced flow occlusion is designed to generate a change in the venous line 
pressure such that the hemodialysis machine will automatically alarm and halt further pumping. 
The V Needle used in this study will have a sharp cannula tip with an anti-stick needle guard. 
1.8 
STUDY RATIONALE 
In patients undergoing hemodialysis for the treatment of end-stage renal disease, Venous Needle 
Dislodgement (VND) is a rare, but potentially fatal situation in which the needle delivering a 
patient’s blood back to the body after filtration by a dialysis machine becomes inadvertently 
disconnected from the patient. The use of the V Needle as a venous needle return is designed to 
significantly reduce patient risk from exsanguination-related injury or death. This clinical study 
will serve to confirm safety, performance, and usability of the device during appropriate 
hemodialysis therapy.  During this study, the safety and performance of the V Needle during 
delivery of appropriate hemodialysis therapy will be tested. The study will also assess the 
number of false blood alarms observed under normal operating conditions and the V Needle’s 
usability.  V Needle rates of adverse events and ability to complete the hemodialysis session will 
be compared to the rates recorded using standard available needle sets during hemodialysis 
sessions prior to the use of the Hemotek V Needle. 
1.9 
STUDY POPULATION 
Adult men and women with end-stage renal disease undergoing chronic hemodialysis with a 
mature AV fistula or graft in the arm. 
1.10 CLINICAL SITES 
Between 2 and 4 centers 
1.11 NUMBER OF SUBJECTS 
Between 15 and 20 subjects (at least 87 test sessions required) 
1.12 STUDY DURATION 
The study will be conducted over a maximum of nine (9) dialysis sessions (first three (3) are 
controls) for each patient. Typically, a patient will have three sessions in one week so that the 
study will last three (3) weeks per patient. Each session usually lasts around three hours. Any 
adverse events that are reported after the study session (e.g., a hematoma in the days following 
the session) will also be catalogued and reported. Adverse events will be recorded up until the 
next dialysis treatment or for one week following the last session if no additional sessions are 
planned. 

     
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1.13 INCLUSION CRITERIA 
1. Subjects with end-stage renal disease receiving chronic hemodialysis in a clinical setting. 
2. Subjects must be able to receive hemodialysis with the Hemotek 15-gauge, 1 inch length 
V Needle, with 12 inch tubing. 
3. Age greater than 18 years old at screening. 
4. Vascular access via a mature arteriovenous (AV) fistula or graft in the arm and 
determined to be adequate for a chronic hemodialysis therapy. 
5. AV fistula has already been demonstrated to adequately permit one or more hemodialysis 
sessions. 
6. Subject prescribed blood flow rates between 200 ml/min and 450 ml/min 
7. In women with child-bearing potential, negative urine or serum pregnancy test at 
Screening. 
8. Subject able to communicate effectively with investigative staff, competent and willing to 
give written informed consent, and able to comply with entire study procedures. 
9.  Hemoglobin ≥9 g/dL (consistent with KDOQI guidelines) 
10. Normal platelet count (≥150,000 /mm3) 
11. International Normalized Ratio (INR) ≤ 1.5  
1.14 EXCLUSION CRITERIA 
1. Subjects receiving chronic hemodialysis with a vascular catheter. 
2. Subjects with vascular access that is determined by the clinician to be unacceptable for a 
hemodialysis procedure. 
3. Patients with a bleeding diathesis  
4. Patients receiving anti-coagulants  
5. Previous vascular access surgery (≤30 days from study entry) or planned access surgery  
6. Known hypersensitivity to any imaging agents (e.g., contrast) that may be required 
during the study period  
7. Patients with confirmed vasculitis  
8. Vascular access infection or systemic active infection within 30 days of study entry  
9. Life expectancy less than 12 months  
10. Planned renal transplantation or planned conversion to peritoneal dialysis  
11. Subjects with any condition determined by the investigator that precludes them from 
safely participating in the study. 
12. Female participants at the time of consent to the study cannot be breastfeeding or pregnant. 
1.15 PRIMARY SAFETY MEASURE 
Rate of serious adverse device events (SADEs) 
1.16 ADDITIONAL SAFETY MEASURES 
• Rate of adverse events (AEs) 

     
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• Rate of serious adverse events (SAEs) 
• Rate of adverse device events (ADEs) 
• Rate of adverse procedure events (APEs) 
• Rate of serious adverse procedure events (SAPEs) 
1.17 PRIMARY PERFORMANCE MEASURES 
Percentage of successful hemodialysis sessions with the Hemotek device. 
1.18 SECONDARY PERFORMANCE MEASURES 
No powered secondary performance measures are planned. 
1.19 ADDITIONAL PERFORMANCE MEASURES 
• Machine alarm rate (blood alarms only) during hemodialysis therapy, including false 
alarms and relationship of alarm to venous needle 
• Changes to blood flow rate setting during therapy sessions and relationship to venous 
needle 
• Venous, transmembrane, and/or arterial pressure measurements  
• Patient survey including ratings for venous needle comfort and feelings of safety (V 
Needle only) 
• Clinician survey, evaluating the following items: 
o use of the device according to the instructions for use (IFU) 
o ability to properly cannulate 
o ability to objectively see flashback 
o confirmation that the footplate is fully depressed (V Needle only) 
o feelings regarding patient risk (V Needle only) 
• Achieved treatment time 
• Achieved blood flow rate 
• Ability to cannulate fistula 
• Episodes of partial or complete needle dislodgment 
1.20 STUDY DESIGN 
The study is an open-label, non-randomized, single arm, multi-center trial with subject’s serving 
as their own control. For the first three (3) control sessions, subjects will undergo usual 
hemodialysis sessions with a commercially available device.  For the remaining six (6) sessions, 
subjects will be cannulated with a V Needle in place of a usual venous line AV fistula set.   
The hemodialysis sessions will be conducted in the clinic. Subjects will be observed by a 
clinician for the duration of each session. Clinicians will monitor the session for any abnormal 
disruptions, therapy interruptions, and/or adverse events, including hemolysis, due to V Needle 
presence.  All machine blood alarms, therapy interruptions, and/or partial or complete needle 

     
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dislodgements will be recorded and immediately corrected.  Clinicians will be responsible for 
identifying adverse events as they occur and will activate established facility emergency 
response plans if necessary. A clinician will perform cannulation. 
Cannulation site and surrounding tissue will be examined by the nurse and assessed for any 
locally induced trauma before and after treatment.  
A survey will be completed by the clinicians and patients to assess usability, comfort, and 
feelings of safety of the V Needle. 
1.21 SAMPLE SIZE JUSTIFICATION 
The sample size was determined to compare the rate of successful treatments between 
hemodialysis sessions with the test needle compared to the control needle.  
The hypothesis test for the primary performance measure is defined as follows:  
𝐻!: 𝑝" −𝑝# ≤  -d 
𝐻$: 𝑝" −𝑝# >  -d 
where pT is the probability of a successful hemodialysis treatment session with the V Needle 
(test), 𝑝# is the probability of a successful hemodialysis treatment session with a commercially 
available device (control), and d is the non-inferiority margin.   
This sample size estimation is based on the following assumptions: 
• 
The expected success rate for both devices is 98%  
• The expected difference between the test and control treatment groups is 0% 
• There is a test-to-control sampling ratio of 2:1 
• A non-inferiority margin of 8% (d = 0.08)  
• Use of a one-sided Farrington-Manning Score Test with 85% power and at a one-sided 
2.5% significance level  
Based on these assumptions, a statistically powered sample size of 87 test (V Needle) sessions is 
required for the primary endpoint1,2. 
The total sample size is therefore determined to be 108 test sessions with 18 subjects required to 
account for 20% attrition and/or any of the 6 V Needle sessions being missed.  
The primary performance analysis will test the non-inferiority hypothesis as a difference of 
proportions between the test and control groups using a one-sided Farrington-Manning Score Test 
at a significance level of α=0.025. 
 
1 Chow, S.C., Shao, J., and Wang, H. 2008. Sample Size Calculations in Clinical Research, Second Edition. 
Chapman & Hall/CRC. Boca Raton, Florida. 
2 Farrington, C. P. and Manning, G. 1990. 'Test Statistics and Sample Size Formulae for Comparative Binomial 
Trials with Null Hypothesis of Non-Zero Risk Difference or Non-Unity Relative Risk.'  Statistics in Medicine, Vol. 
9, pages 1447-1454. 

     
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Additionally, the primary performance measure will be analyzed on the subject-level (utilizing a 
non-inferiority margin of 0.05) by testing the difference in mean success rates per subject across 
treatment groups using a one-sided paired t-test at a significance level of α=0.025. 
1.22 STUDY TIMELINE 
Month 0: Site identification and IRB approvals; study start-up and training  
Month 2:  First patient enrolled 
Month 5:  Last patient enrolled 
Month 6:  Data analysis 
Month 7:  Completion of study report 
 
 

     
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1.23 SCHEDULE OF ACTIVITIES (SOA) 
Table 1:  Schedule of Activities 
 
Enrollment 
Visit 
Control Dialysis  
Sessions  
(Visit 1-3) 
Test Dialysis  
Sessions  
(Visit 4-9) 
Final Study 
Visit 
(7-10 days 
after Visit 9) 
Informed Consent 
X 
 
 
 
Inclusion/Exclusion 
X 
 
 
 
Demographics 
X 
 
 
 
Medical History Form 
X 
 
 
 
Vital Signs 
X 
 
 
 
Adverse Event Form 
X 
X 
X 
X 
Therapy Assessment Form, 
including the following: 
• 
Treatment success/failure 
• 
Blood alarms 
• 
Flow rates 
• 
Prescribed treatment time 
• 
Achieved treatment time 
• 
Prescribed blood flow rate 
• 
Achieved blood flow rate 
• 
Ability to cannulate fistula 
 
X 
X 
 
Patient Survey 
 
 
X 
 
Clinician Survey 
 
X 
X 
 
 
1.24 STUDY PARTICIPANT DURATION 
It is expected that the visits will occur at sequential dialysis sessions such that the patient 
participation is limited to an enrollment visit and then approximately three (3) weeks of follow-
up visits.  No windows are provided for these visits, but the entire sequence shall occur within 40 
days from the baseline visit.  
 
 

     
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2 Statement of Compliance 
The trial will be carried out in accordance with International Conference on Harmonisation Good 
Clinical Practice (ICH GCP) and the following: 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 
CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 
812) 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are 
responsible for the conduct, management, or oversight of NIH-funded clinical trials have 
completed Human Subjects Protection and ICH GCP Training. 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the Institutional Review Board (IRB) for review and approval.  Approval of both 
the protocol and the consent form must be obtained before any participant is enrolled.  Any 
amendment to the protocol will require review and approval by the IRB before the changes are 
implemented to the study.  In addition, all changes to the consent form will be IRB-approved; a 
determination will be made regarding whether a new consent needs to be obtained from 
participants who provided consent, using a previously approved consent form. 
 
Investigator Name (please print): 
__________________________________________ 
Investigator Signature: 
__________________________________________ 
Date: 
__________________________________________ 
 
 

     
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3 Introduction 
3.1 
Study Rationale 
In patients undergoing hemodialysis for the treatment of end-stage renal disease, Venous Needle 
Dislodgement (VND) is a rare, but potentially fatal situation in which the needle delivering a 
patient’s blood back to the body after filtration by a dialysis machine becomes inadvertently 
disconnected from the patient. Hemotek Medical Inc. has developed the V Needle, a venous 
needle return that is designed to reduce patient risk from exsanguination-related injury or death. 
This clinical study will serve as a confirmatory study to gain FDA marketing clearance of the 
Hemotek V Needle system in the clinical setting. During this study, we will determine the ability 
of the V Needle to successfully deliver appropriate hemodialysis therapy per the facility’s 
guidelines.  It will also be used to determine if the V Needle triggers false blood alarms under 
normal operating conditions. This study will also be used to demonstrate the V Needle meets 
effective usability criteria. Rates of adverse events and ability to complete the hemodialysis 
session will be compared to the rates recorded using commercially available devices during the 
hemodialysis sessions prior to the use of the Hemotek V Needle. 
3.2 
Background 
Every week in the US, more than 500,000 patients collectively undergo >1,500,000 dialysis 
sessions which is equivalent to > 70,000,000 dialysis sessions per year, each about 3 hours long.  
A potentially devastating complication of hemodialysis is venous needle dislodgement (VND) 
whereby the needle returning blood into a patient’s body accidently becomes withdrawn from the 
arm.  If undetected, the blood loss quickly becomes injurious or, worse, can lead to death.  
A device that aims to detect VND, but does not disrupt the flow of the dialysis machine, is the 
RedSense device. The device uses an optical sensor to activate a light and sound alarm when a 
VND is detected.  For this device, the alarm functioned correctly in 92.5% of tests, and after 
device modification, the device operated in 97.2% of tests3. 
While the RedSense device can trigger an alarm when a VND occurs, there is no single, 
inexpensive and easy-to-use method that can both detect VND and immediately shut down the 
flow of blood through the needle.  To address this glaring need in the dialysis marketplace, 
Hemotek has developed the V Needle, a single-use disposable needle with built-in VND 
protection.  It has an elegant mechanical mechanism that is designed to automatically occlude the 
flow of blood during dislodgement and trigger the dialysis machine pump to shut down.  
 
3 Ahlmen et al., 2008.  “A new safety device for hemodialysis” Hemodialysis International 2008; 12:264–267. 

     
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3.3 
Risk/Benefit Assessment 
3.3.1  Known Potential Risks 
Risks related to the study and/or device are expected to be the same as those risks for patients 
undergoing hemodialysis.  Due to the design of the V Needle, very slight increases in certain 
risks are potentially possible but are not expected.   
The potential risks specifically associated with the V Needle are as follows: 
• Improper needle function, leading to machine false alarms or changes to dialysis 
blood flow rate or pressure 
• Difficulty inserting the needle into the veins (cannulation) 
• Slightly increased risk of blood loss and/or air embolism 
The risks associated with all AV fistula sets are as follows: 
• Air in the tubing/blood vessels, which could result in blockage and reduced blood 
flow in that vessel or other vessels in the body 
• Allergic responses to the device materials, such as swelling, itchiness, or 
inflammation of the skin 
• Small particles released into the blood vessels, which could result in blockage and 
reduced blood flow in that vessel or other vessels in the body 
• Improper function of the device, leading to delay in therapy 
• Infection 
• Breakdown of blood cells due to unstable blood flow (hemolysis), which can lead 
fatigue, dizziness, and headaches   
• Blood loss 
• Blood leaks into surrounding tissue, leading to swelling and/or pain (infiltration, 
when the needle tip is placed into the body but not directly into the blood vessel) 
• Injury from sharp needle 
3.3.2   Known Potential Benefits 
The primary benefit for participation in the study is to have access to a new device that can 
potentially detect VND.  Additionally, future patients may benefit from this potentially life-
saving device, and the knowledge gained about the device and study design in this study are 
required first steps in bringing the device to market. 
3.3.3  Assessment of Potential Risks and Benefits 
The risks to study subjects beyond those normally associated with hemodialysis are due to the 
slight force from the footplate on the access site and the presence of the flexible membrane 
inside the V Needle. There may be a slightly increased risk of blood loss and/or air embolism, 
but based on laboratory testing and subject matter expert input, these harms are not expected to 
occur more frequently than in usual dialysis sessions. Due to the potentially improved safety 
profile through the use of the device and potential for bringing a potentially life-saving device to 
market, the value of the knowledge gained through this study are judged to outweigh the risks 
incurred by study participation. 

     
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4 Objectives and Endpoints 
The study is designed to confirm the safety, performance, and usability of the Hemotek V Needle 
A.V. Fistula Set for temporary cannulation for hemodialysis in the treatment of end-stage renal 
disease patients in the clinical setting. 
Because the objective of the study is confirmation of safety, performance, and usability, a 
number of endpoints are collected to ensure that the safety, performance, and usability of the 
device can be evaluated.   
4.1 
PRIMARY SAFETY MEASURE 
Rate of serious adverse device events (SADEs) 
4.2 
ADDITIONAL SAFETY MEASURES 
• Rate of adverse events (AEs) 
• Rate of serious adverse events (SAEs) 
• Rate of adverse device events (ADEs) 
• Rate of adverse procedure events (APEs) 
• Rate of serious adverse procedure events (SAPEs) 
4.3 
PRIMARY PERFORMANCE MEASURES 
Percentage of successful hemodialysis sessions with the Hemotek device. 
4.4 
ADDITIONAL PERFORMANCE MEASURES 
• Machine alarm rate (blood alarms only) during hemodialysis therapy, including false 
alarms and relationship of alarm to venous needle 
• Changes to blood flow rate setting during therapy sessions and relationship to venous 
needle 
• Venous, transmembrane, and/or arterial pressure measurements  
• Patient survey including ratings for venous needle comfort and feelings of safety (V 
Needle only) 
• Clinician survey, evaluating the following items: 
o use of the device according to the instructions for use (IFU) 
o ability to properly cannulate 
o ability to objectively see flashback 
o confirmation that the footplate is fully depressed (V Needle only) 
o feelings regarding patient risk (V Needle only) 
• Achieved treatment time 
• Achieved blood flow rate 
• Ability to cannulate fistula 

     
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• Episodes of partial or complete needle dislodgment 
5 Study Design 
5.1 
Overall Design 
This study is a prospective, multi-center, single-arm study with subjects acting as their own 
control designed to confirm the safety, performance, and usability of the V Needle, a new safety 
needle for use during in-clinic hemodialysis that is designed to automatically generate a partial 
occlusion of the internal fluid path and trigger the hemodialysis machine to alarm and shut off if a 
complete dislodgement of the venous needle from the arm inadvertently occurs. 
For the first three (3) control sessions, consenting subjects will undergo usual hemodialysis 
sessions with a commercially available device.  For the remaining six (6) test sessions, subjects 
will be cannulated with a V Needle in place of a usual venous line AV fistula set.   
The hemodialysis sessions will be conducted in the clinic. Subjects will be observed by a 
clinician for the duration of each session. Clinicians will monitor the session for any abnormal 
disruptions, therapy interruptions, and/or adverse events, including hemolysis, due to V Needle 
presence.  All machine blood alarms, therapy interruptions, and/or partial or complete needle 
dislodgements will be recorded and immediately corrected.  Clinicians will be responsible for 
identifying adverse events as they occur and will activate established facility emergency 
response plans if necessary. A clinician will perform cannulation. 
Cannulation site and surrounding tissue will be examined by the nurse and assessed for any 
locally induced trauma before and after treatment.  
A survey will be completed by the users to assess usability of the V Needle. 
After the first five (5) patients will be enrolled, and data through the last visit of the fifth patient 
is available, this data will be submitted to the FDA while study enrollment and visits continue. 
No Hemotek Medical V Needle treatments will occur until after FDA has reviewed the data from 
the first 5 patients and allows the study to proceed. Data will also be submitted to the FDA after 
the tenth patient completes their last visit and data is available. After the tenth patient, study 
enrollment and visits can continue, but no Hemotek Medical V Needle treatments will occur on 
the final 5-10 patients until the FDA allows the study to proceed.  After FDA has found the data 
for the first 10 patients acceptable, the rest of the study can continue until the end. 
At least two different clinicians will evaluate the device for each patient and for each needle for 
that patient (test and control) to minimize the bias associated with the same clinician evaluating 
all of the sessions for a given subject.   
5.2 
Scientific Rationale for Study Design 
The study is designed to confirm the safety, performance, and usability of the V Needle, a new 
medical device.  The device will be tested by comparing the ability to successfully complete 
hemodialysis sessions to commercially available devices as determined by a clinician.  

     
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Additionally, the rates of adverse events will be compared to rates measured using commercially 
available devices, providing a comparator with data collected under similar circumstances and in 
the same patient population. 
5.3 
End of Study Definition 
A participant is considered to have completed the study if they have completed all follow-up 
visits. It is expected that 15 subjects will undergo 9 treatments each.  In the event that some of 
these patients do not complete the full set of treatments, additional subjects (up to 20 total) will 
be recruited until 87 V Needle treatments are completed and all patients have completed their 
study visits.  
After the first five (5) patients will be enrolled, and data through the last visit of the fifth patient 
is available, this data will be submitted to the FDA while study enrollment and visits continue. 
No Hemotek Medical V Needle treatments will occur until after FDA has reviewed the data from 
the first 5 patients and allows the study to proceed. Data will also be submitted to the FDA after 
the tenth patient completes their last visit and data is available. After the tenth patient, study 
enrollment and visits can continue, but no Hemotek Medical V Needle treatments will occur on 
the final 5-10 patients until the FDA allows the study to proceed.  After FDA has found the data 
for the first 10 patients acceptable, the rest of the study can continue until the end. 
If there are any deaths or three SADEs during the study device period that require medical or 
surgical intervention, study enrollment and further visits will be stopped, and an assessment (in 
conjunction with the DSMB and FDA) will be enacted. 
6 Study Population 
6.1 
Inclusion Criteria 
In order to be eligible to participate in this study, an individual must meet all of the following 
criteria: 
1. Subjects with end-stage renal disease receiving chronic hemodialysis in a clinical setting. 
2. Subjects must be able to receive hemodialysis with the Hemotek 15-gauge, 1 inch length 
V Needle, with 12 inch tubing. 
3. Age greater than  18 years old at screening. 
4. Vascular access via a mature arteriovenous (AV) fistula or graft in the arm and 
determined to be adequate for a chronic hemodialysis therapy. 
5. AV fistula has already been demonstrated to adequately permit one or more hemodialysis 
sessions. 
6. Subject prescribed blood flow rates between 200 ml/min and 450 ml/min 
7. In women with child-bearing potential, negative urine or serum pregnancy test at 
Screening. 
8. Subject able to communicate effectively with investigative staff, competent and willing to 
give written informed consent, and able to comply with entire study procedures. 
9. Hemoglobin ≥9 g/dL (consistent with KDOQI guidelines)  

     
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10. Normal platelet count (≥150,000 /mm3) 
11. International Normalized Ratio (INR) ≤ 1.5  
6.2 
Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation in this 
study: 
1. Subjects receiving chronic hemodialysis with a vascular catheter. 
2. Subjects with vascular access that is determined by the clinician to be unacceptable for a 
hemodialysis procedure. 
3. Patients with a bleeding diathesis  
4. Patients receiving anti-coagulants  
5. Previous vascular access surgery (≤30 days from study entry) or planned access surgery  
6. Known hypersensitivity to any imaging agents (e.g., contrast) that may be required 
during the study period  
7. Patients with confirmed vasculitis  
8. Vascular access infection or systemic active infection within 30 days of study entry  
9. Life expectancy less than 12 months  
10. Planned renal transplantation or planned conversion to peritoneal dialysis  
11. Subjects with any condition determined by the investigator that precludes them from 
safely participating in the study. 
12. Female participants at the time of consent to the study cannot be breastfeeding or pregnant. 
 
6.3 
Screen Failures 
Individuals who sign informed consent, but are then discovered to not meet the inclusion and 
exclusion criteria and/or who do not complete the Control Dialysis Sessions will be considered 
screen failures.  These subjects will not be included in the subject count.  Information about the 
subject’s demography, screen failure details, eligibility criteria, and any adverse events that 
occur prior to screen failure will be collected.  Subjects who are screen failures may be 
rescreened if deemed appropriate (e.g., they need to allow their fistula to mature).  Rescreened 
subjects should be assigned their original patient number. 
6.4 
Strategies for Recruitment and Retention 
Subjects will be recruited from the study center’s regular pool of patients undergoing 
hemodialysis.  Due to the number of subjects required for this study, additional advertising 
and/or recruitment methods should not be required. 
Additionally, because each patient is expected to complete the study in approximately one 
month, no exceptional retention methods will be used.  A payment (via check) in an amount of 
$50 per visit will be provided to the subjects to cover the subjects’ additional time and/or 
expenses at the completion of the final visit. 

     
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7 Study Intervention 
7.1 
Study Intervention(s) Administration 
7.1.1  Study Intervention Description 
The Hemotek V Needle A.V. Fistula Set is intended for temporary cannulation (non-implanted) 
to vascular access for extracorporeal blood treatment for hemodialysis. Please refer to device 
labeling for additional information.  The device is intended for single use only. The device also 
has an integrated safety mechanism that is designed to automatically occlude the internal fluid 
path and trigger the hemodialysis machine to alarm and shut off if a complete dislodgement of 
the venous needle from the arm inadvertently occurs. 
For the clinical studies, the Hemotek 15-gauge, 1 inch length, with 12 inch tubing, V Needle 
Sharp configuration will be used. Devices will be packaged individually, and a clamp will be 
used.  
7.2 
Preparation/Handling/Storage/Accountability 
7.2.1   Acquisition and accountability 
The devices will be hand-delivered to the investigative site.  Product that is not immediately in 
use will be stored in a locked cabinet.  Expired or unused product will be retrieved by the 
sponsor. 
7.2.2   Formulation, Appearance, Packaging, and Labeling 
The device will be provided with appropriate packing and labeling, including a clear indication 
of the expiration date of the product.  The device will be provided sterile. 
7.2.3    Product Storage and Stability 
The storage requirements will be indicated by the device packaging and labeling.  The devices 
are single use.  The expiration date of the device will be clearly indicated on the device. 
7.2.4    Preparation 
Refer to the device’s instruction for use for appropriate administration of the device. 
7.3 
Measures to Minimize Bias: Randomization and Blinding 
The study is not randomized or blinded.  Control sessions measuring the rates of adverse events 
and successful therapy sessions is included to provide a within-subject comparator to these rates 
for the V Needle.  To minimize bias, subjects will be considered and asked to enroll in the study 
sequentially to the extent possible to ensure that no unconscious bias of patient selection occurs.  
The study will be conducted at multiple centers to ensure that outcomes are able to be 
generalized across different clinics.  
At least two different clinicians will evaluate the device for each patient and for each needle for 
that patient (test and control) to minimize the bias associated with the same clinician evaluating 
all of the sessions for a given subject.   

     
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7.4 
Study Intervention Compliance 
Adherence to the study protocol will be accomplished by the direct supervision of the study 
clinicians and review of the clinical data by study monitors. 
8 Study Intervention Discontinuation and Participant 
Discontinuation/Withdrawal 
8.1 
Discontinuation of Study Intervention 
Discontinuation from one study visit does not mean discontinuation from the study, and 
remaining study procedures should be completed as indicated by the study protocol.  If a 
clinically significant finding is identified (including, but not limited to changes from baseline) 
after enrollment, the investigator or qualified designee will determine if any change in participant 
management is needed. Any new clinically relevant finding will be reported as an adverse event 
(AE). 
8.2 
Participant Discontinuation/Withdrawal from the Study 
Participants are free to withdraw from participation in the study at any time upon request. 
A patient who is no longer active in the study, due either to patient choice or physician 
recommendation, will be classified as a “Withdrawal.”  All completed case report forms up to 
the point of withdrawal must be completed.  
After a patient has been withdrawn from the study or after a patient has withdrawn his/her 
consent, for whatever reason, additional data may no longer be collected after the point of 
withdrawal. All open adverse events should be closed or documented as chronic. Data collected 
up to the point of patient withdrawal may be used for analysis. The sponsor will not actively 
collect any information on subjects who have been withdrawn from the study. However, all post-
withdrawal adverse events of which the sponsor is notified will be recorded in the patient file. 
The reason for participant discontinuation or withdrawal from the study will be recorded on the 
Study Completion Form (CRF).  
8.3 
Lost to Follow-Up 
A participant will be considered lost to follow-up if he or she fails to return for any scheduled 
visit and is unable to be contacted by the study site staff.  
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit: 

     
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• The site will attempt to contact the participant and reschedule the missed visit and 
counsel the participant on the importance of maintaining the assigned visit schedule and 
ascertain if the participant wishes to and/or should continue in the study. 
• Before a participant is deemed lost to follow-up, the investigator or designee will make 
every effort to regain contact with the participant (where possible, 3 telephone calls 
and/or written communication). These contact attempts should be documented in the 
participant’s medical record or study file.  
• Should the participant continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up. 
9 Study Assessments and Procedures 
This section describes the study assessments and procedures.  Refer to Table 1 for a list of the 
data to be collected at each visit.  Study staff will check for AEs at each visit and fill out an AE 
form as necessary. 
9.1 
Efficacy Assessments 
9.1.1  Enrollment 
At the enrollment visit, the informed consent document and inclusion/exclusion criteria will be 
assessed and entered into the Inclusion/Exclusion Case Report Form.  Multiple visits to complete 
the screening and obtain appropriate informed consent are allowed.  Demographics and medical 
history will be collected, as well as vital signs (height, weight, blood pressure, heart rate, 
respiration, and temperature).   
9.1.2   Control Dialysis Sessions 
The assessment of the ability to successfully complete the session will be determined by the 
clinician and recorded on the Therapy Assessment Case Report Form (CRF).  The actual 
treatment time will also be recorded.  Adverse events will be recorded on an Adverse Event Case 
Report Form.  Photos of the cannulation may be taken. 
Additional performance measures include the following: 
• Machine alarm rate (blood alarms only) during hemodialysis therapy, including false 
alarms and relationship of alarm to venous needle 
• Changes to blood flow rate setting during therapy sessions and relationship to venous 
needle 
• Venous, transmembrane, and/or arterial pressure measurements  
• Clinician survey, evaluating the following items: 
o use of the device according to the instructions for use (IFU) 
o ability to properly cannulate 
o ability to objectively see flashback 
• Achieved treatment time 
• Achieved blood flow rate 
• Ability to cannulate fistula 
• Episodes of partial or complete needle dislodgment  

     
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In the event that the venous needle becomes 1) completely dislodged, or 2) partially dislodged 
and the venous pressure increases by more than 40 mm Hg indicating some disruption of the 
fluid flow, the event should be recorded on the therapy assessment and AE CRFs and appropriate 
laboratory tests (including CBC, plasma hemoglobin concentration, serum electrolytes) shall be 
obtained.   
Patients shall be monitored for symptoms of hemolysis; if hemolysis is suspected, an AE form 
should be completed and appropriate laboratory tests (including CBC, plasma hemoglobin 
concentration, serum electrolytes) shall be obtained. 
9.1.3 Test Dialysis Sessions 
The assessment of the ability to successfully complete the session will be determined by the 
clinician and recorded on the Therapy Assessment Case Report Form (CRF).  The actual 
treatment time will also be recorded.  Adverse events will be recorded on an Adverse Event Case 
Report Form.  Photos of the cannulation may be taken. 
Additional performance measures include the following: 
• Machine alarm rate (blood alarms only) during hemodialysis therapy, including false 
alarms and relationship of alarm to venous needle 
• Changes to blood flow rate setting during therapy sessions and relationship to venous 
needle 
• Venous, transmembrane, and/or arterial pressure measurements  
• Patient survey including ratings for venous needle comfort and feelings of safety (V 
Needle only) 
• Clinician survey, evaluating the following items: 
o use of the device according to the instructions for use (IFU) 
o ability to properly cannulate 
o ability to objectively see flashback 
o confirmation that the footplate is fully depressed (V Needle only) 
o feelings regarding patient risk (V Needle only) 
• Achieved treatment time 
• Achieved blood flow rate 
• Ability to cannulate fistula 
• Episodes of partial or complete needle dislodgment 
 
In the event that the venous needle becomes 1) completely dislodged, or 2) partially dislodged 
and the venous pressure increases by more than 40 mm Hg (above last recorded venous pressure 
measurement) indicating some disruption of the fluid flow, the event should be recorded on the 
therapy assessment and AE CRFs and appropriate laboratory tests (including CBC, plasma 
hemoglobin concentration, serum electrolytes) shall be obtained.   
Patients shall be monitored for symptoms of hemolysis; if hemolysis is suspected, an AE 
form should be completed and appropriate laboratory tests (including CBC, plasma 
hemoglobin concentration, serum electrolytes) shall be obtained. 
 
 

     
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9.1.4 Final Study Visit 
7-10 days after the last study visit, subjects will be contacted by phone or will be interviewed at 
their usual hemodialysis session to ensure no additional AEs have occurred. 
 
9.2 
Safety and Other Assessments 
9.2.1  Adverse Event Definitions 
Adverse event forms will be filled out whenever an adverse event occurs within the reportable 
period.  Definitions of the adverse event categories can be found below.  Adverse events will be 
categorized according to a medical dictionary created by the sponsor and approved by the Data 
Safety Monitoring Board (DSMB) for reporting purposes. 
Adverse Event 
(AE) 
Any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in participants, users, 
or other persons, whether or not related to the investigation medical device. 
Note:  Pain and/or bleeding that is to be expected due to hemodialysis during 
the intervention are not considered untoward events and should not be 
recorded as adverse events. Likewise, minimal bruising, pain, and/or bleeding 
in the days following the procedure shall not be considered untoward and not 
considered an AE.  In contrast, any pain, bruising, or bleeding that is 
considered by the clinician to be unusual in magnitude or duration shall be 
considered an AE.   
Adverse 
Device Effect 
(ADE) 
Adverse event related to the use of an investigational medical device. 
Note: this definition includes adverse events resulting from insufficient or 
inadequate Instructions for Use, deployment, implantation, installation, or 
operation, or any malfunction of the investigational medical device. This 
definition includes any event resulting from use error or from intentional 
misuse of the investigational medical device.  
Adverse 
Procedure 
Effect (APE) 
Adverse event related to the therapeutic procedure for the investigational 
medical device. 
Device 
Deficiencies 
(DD) 
Any inadequacy in the identity, quality, durability, reliability, safety, or 
performance of an investigational device, including malfunction, use errors or 
inadequacy in information supplied by the manufacturer. 
Serious 
Adverse Event 
(SAE) 
Any adverse event that led to any of the following: 
• death 
• serious deterioration in the health of the participant that either 
resulted in:  
§ a life-threatening illness or injury,  
§ a permanent impairment of a body structure or a body 
function, 

     
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§ hospitalization or prolongation of patient 
hospitalization, 
§ medical or surgical intervention to prevent life-
threatening illness or injury or permanent impairment 
to a body structure or a body function, 
§ chronic disease  
• fetal distress, fetal death or a congenital physical or mental 
impairment or birth defect 
Note: Planned hospitalization for a pre-existing condition, or a procedure 
required by the clinical investigational plan (CIP), without serious 
deterioration in health, is not considered a serious adverse event.  
Serious 
Adverse 
Device Effect 
(SADE) 
An adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event.  
Serious 
Adverse 
Procedure 
Effect (SAPE) 
An adverse procedure effect that has resulted in any of the consequences 
characteristic of a serious adverse event.  
Unanticipated 
Serious 
Adverse 
Device Effect 
(USADE) 
Serious adverse device effect which by its nature, incidence, severity, or 
outcome has not been identified in the current version of the risk analysis 
report  
Note: Anticipated serious adverse device effect (ASADE) is an effect which 
by its nature, incidence, severity, or outcome has been identified in the risk 
analysis report.  
9.2.2  AE and Device Deficiency Documentation 
All AEs will be monitored for all participants, from the time of signing consent through to the 
final study visit. All AEs, including SAEs, must be detailed in the source documents and 
reported in a timely manner to the Sponsor by completing an AE page in the CRF. Each unique 
event must be documented separately.   
AEs can be based upon subject report, questionnaires, medical reports or other medical 
examinations. AEs should be documented in terms of a medical diagnosis. When this is not 
possible, the AE should be documented in terms of signs and/or symptoms observed by the 
Investigator or reported by the subject at each study visit. For each medical diagnosis or sign 
and/or symptoms the Investigator will provide information on dates (onset/resolution), severity, 
relationship to the medical device, action(s) taken and outcome. 
Any AEs should be followed until the event is resolved (with or without sequelae). If an event is 
ongoing at the time of study completion or termination, the participant will be followed until 
resolution or Investigator determination that the subject’s condition is stable. Documentation of 
stabilization must be recorded in the participant’s source documents. If the Investigator learns of 
any SAE at any time after a participant has been discharged from the study, and he/she considers 

     
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the event reasonably related to the study device and/or study procedure, the Investigator will 
record the occurrence in the subject ’s source documents and promptly notify the Sponsor. 
If adverse events occur, the first concern will be the safety of the subject. Appropriate medical 
intervention will be made as soon as possible. Treatment of any AEs is at the sole discretion of 
the Investigator and according to current good medical practice. Any medication administered 
for the treatment of an AE should be recorded in the CRF. 
All device deficiencies, including serious incidents (a device deficiency that might have led to a 
SADE if a) suitable action had not been taken, b) intervention had not been made, c) if 
circumstances had been less fortunate), shall be documented throughout the study in the source 
documents and appropriately reported on a device deficiency page of the CRF. 
9.2.3  Reporting of events  
AEs must be reported to the Sponsor or designee by the Investigator immediately but no later 
than 3 calendar days after investigation site study personnel’s awareness of the event of the 
following: 
i. 
SAE, 
ii. 
SADE, 
iii. 
SAPE, 
iv. 
USADE, 
v. 
Device deficiency (DD) that might have led to a serious adverse event if appropriate 
action had not been taken, intervention had not occurred, or circumstances had been less 
fortunate, 
vi. 
New findings in relation to any event mentioned to in points i) to v). 
 
Notification should be made by completion of the AE form in the CRF and by contacting by 
phone and/or by email the sponsor or designee.  
As additional information becomes available, the event should be updated in the CRF and 
provided to the sponsor or designee. 
Non-serious AEs should be reported at the next routine contact. 
9.2.4  AE and DD information and Classification 
The Investigator will classify each AE and DD according to the Adverse Event Form. If the AE 
is serious or the Investigator feels that the device contributed in any way to the AE, the 
Investigator must report the event to the Sponsor and the EC, if applicable, as per above.  It is the 
Investigators responsibility to assess the intensity of, as well as determine the causality and 
potential relationship of the event to the study device or procedure.  The Sponsor may ask for 
further clarification and information to support the AE classification. If sufficient questions arise, 
the Sponsor may ask the DSMB to adjudicate the classification. The Sponsor may assess the 
potential relationship to the device or procedure differently than the Investigator; in that case, 
both conclusions will be collected and reported, if applicable. 
The following information will be collected for any event occurring during the course of this 
investigation: 
• Date of event onset, 

     
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• In case of SAE, SADE, SAPE, USADE, DD that might have led to a SAE in other 
circumstances: classification of the event (death - life-threatening illness or injury - 
permanent impairment/chronic disease – hospitalization - medical or surgical intervention 
- fetal distress, fetal death or congenital physical or mental or birth defect) 
• Description of the event 
• Action / treatment / patient outcome 
• Intensity of the event (mild, moderate, severe) 
• Relationship to procedure (not related, possible, definite) 
• Relationship to study device (not related, possible, definite) 
• Event status (resolved, resolved with sequelae, ongoing, death) 
 
9.2.5  Emergency contact details for reporting reportable events 
Sponsor and designee contact details for reporting reportable events are detailed in the study 
contacts at the beginning of the present clinical investigation plan. 
9.2.6  Safety Monitoring 
Safety oversight will be under the direction of a Data Safety Monitoring Board (DSMB).  The 
DSMB shall be independent from the study conduct and free of conflict of interest, or measures 
should be in place to minimize perceived conflict of interest. The DSBM will operate under the 
rules of an approved charter that will be written by the sponsor and reviewed and approved by 
the DSMB.  
The DSMB will be responsible for initial review of all events reported as serious. Further 
information may be sought from the investigational site.  Events will be reviewed to check 
relatedness and seriousness to enable appropriate reporting to the ethics and regulatory bodies, as 
well as take any appropriate action with regards to study continuation. 
The DSMB will include at least two physicians who have experience with hemodialysis and 
vascular access and one statistician. 
9.2.7 Definition of Adverse Events (AE) 
Adverse event means any untoward medical occurrence associated with the use of an 
intervention in humans, whether or not considered intervention-related. 
Note:  Pain and/or bleeding that is to be expected due to hemodialysis during the intervention are 
not considered untoward events and should not be recorded as adverse events. Likewise, minimal 
bruising, pain, and/or bleeding in the days following the procedure shall not be considered 
untoward and not considered an AE.  In contrast, any pain, bruising, or bleeding that is 
considered by the clinician to be unusual in magnitude or duration shall be considered an AE.  
9.2.8 Definition of Serious Adverse Events (SAE) 
An adverse event (AE) or suspected adverse reaction is 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, or a congenital anomaly/birth defect. 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 

     
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surgical intervention to prevent one of the outcomes listed in this definition. Examples of such 
medical events include allergic bronchospasm requiring intensive treatment in an emergency 
room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, 
or the development of drug dependency or drug abuse. 
9.2.9  Classification of an Adverse Event  
9.2.10 Severity of Event 
The following guidelines will be used to describe severity of AEs: 
 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities.  For cannulation injuries, An injury that may result in bleeding, infiltration, and 
swelling that may be treated with conservative measures such as ice and rest for 1 to 2 days; 
cannulation can be reattempted for the next dialysis session. The access should be successfully 
recannulated with 2 needles in ≤7 days.2 Even a minor cannulation injury may require the use of 
a temporary catheter. 
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning.  For cannulation 
injuries, an injury that results in significant bleeding, infiltration, and swelling that requires 
recovery for >7 days. 
• 
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”.   For cannulation injuries, an 
injury that results in significant bleeding complications that requires one of the following: blood 
transfusion, emergency department visit, hospitalization, or endovascular or surgical intervention. 
9.2.11 Relationship to Study Intervention 
All adverse events (AEs) must have their relationship to study device/procedure assessed by the clinician 
who examines and evaluates the participant based on temporal relationship and his/her clinical judgment. 
The degree of certainty about causality will be graded using the categories below. In a clinical trial, the 
study product must always be suspect.  
• 
Definitely Related – The AE is known to occur with the study device/procedure, or it is known 
that the study device/procedure caused the AE. 
• 
Possibly Related -- The AE is could have occurred due to the study device/procedure, there is a 
reasonable possibility that the study device/procedure caused the AE, or there is a temporal 
relationship between the study device/procedure and event. Reasonable possibility means that 
there is evidence to suggest a causal relationship between the study device/procedure and the AE. 
• 
Not Related – There is not a reasonable possibility that the administration of the study 
device/procedure caused the event, there is no temporal relationship between the study 
device/procedure and event onset, or an alternate etiology has been established. 
9.2.12 Expectedness 
The Data Safety Monitoring Board (DSMB) 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. 
9.2.13 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 presenting 
for medical care, or upon review by a study monitor.  

     
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All AEs including local and systemic reactions 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 study product 
(assessed only by those with the training and authority to make a diagnosis), and time of 
resolution/stabilization of the event. All AEs occurring while on study must be documented 
appropriately regardless of relationship. All AEs will be followed to adequate resolution.  
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.  
Study clinicians will record all reportable events with start dates occurring any time after 
informed consent is obtained until 7 days after the last day of study participation.  At each study 
visit, the investigator will inquire about the occurrence of AEs since the last visit.  Events will be 
followed for outcome information until resolution or stabilization.  
10 Statistical Considerations 
10.1 Statistical Hypotheses 
10.1.1 Sample Size 
The sample size was determined to compare the rate of successful treatments between 
hemodialysis sessions with the test needle compared to the control needle.  
The hypothesis test for the primary performance measure is defined as follows:  
𝐻!: 𝑝" −𝑝# ≤  -d 
𝐻$: 𝑝" −𝑝# >  -d 
where pT is the probability of a successful hemodialysis treatment session with the V Needle 
(test), 𝑝# is the probability of a successful hemodialysis treatment session with a commercially 
available device (control), and d is the non-inferiority margin.   
This sample size estimation is based on the following assumptions: 
• 
The expected success rate for both devices is 98%  
• The expected difference between the test and control treatment groups is 0% 
• There is a test-to-control sampling ratio of 2:1 
• A non-inferiority margin of 8% (d = 0.08)  
• Use of a one-sided Farrington-Manning Score Test with 85% power and at a one-sided 
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Based on these assumptions, a statistically powered sample size of 87 test (V Needle) sessions is 
required for the primary endpoint4,5. 
The total sample size is therefore determined to be 108 test sessions with 18 subjects required to 
account for 20% attrition and/or any of the 6 V Needle sessions being missed.  
The primary performance analysis will test the non-inferiority hypothesis as a difference of 
proportions between the test and control groups using a one-sided Farrington-Manning Score Test 
at a significance level of α=0.025. 
Additionally, the primary performance measure will be analyzed on the subject-level (utilizing a 
non-inferiority margin of 0.05) by testing the difference in mean success rates per subject across 
treatment groups using a one-sided paired t-test at a significance level of α=0.025. 
 
10.1.2 Primary Hypothesis 
The primary performance goal for this study is that the Hemotek device will provide successful 
hemodialysis treatment at a rate non-inferior to that of the commercially available devices. The 
rate of successful treatment will be computed as the number of successful session completions of 
V Needle, as determined by the clinician, divided by the total number of sessions attempted.   
To determine whether a dialysis session was successful, clinicians will be asked “Was dialysis 
session incomplete because of a vascular access issue?”  If the answer is “No,” this indicates that 
the dialysis session completed successfully or was stopped for reasons that were not related to 
the vascular access (e.g., patient illness, etc.). 
The null hypothesis is that the difference between the rates of successfully completed 
hemodialysis sessions for the test and control groups is less than or equal to the non-inferiority 
margin (indicating inferior success rate).  Rejection of the null hypothesis indicates the observed 
data supports the alternative hypothesis that the difference between the rates of successfully 
completed hemodialysis session for the test and control groups is at least the non-inferiority 
margin (indicating non-inferior success rate).   
The hypothesis test for the primary analysis are defined as follows:  
𝐻!: 𝑝" −𝑝# ≤  -d 
𝐻$: 𝑝" −𝑝# >  -d 
where pT is the probability of a successful hemodialysis treatment session with the V Needle 
(test), 𝑝# is the probability of a successful hemodialysis treatment session with a commercially 
available device (control), and d is the non-inferiority margin.   
 
4 Chow, S.C., Shao, J., and Wang, H. 2008. Sample Size Calculations in Clinical Research, Second Edition. 
Chapman & Hall/CRC. Boca Raton, Florida. 
5 Farrington, C. P. and Manning, G. 1990. 'Test Statistics and Sample Size Formulae for Comparative Binomial 
Trials with Null Hypothesis of Non-Zero Risk Difference or Non-Unity Relative Risk.'  Statistics in Medicine, Vol. 
9, pages 1447-1454. 

     
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10.2 Populations for Analyses 
Subjects will be analyzed by gender, demographics, and by site to ensure that results are 
consistent across these variables. 
10.3 Statistical Analyses 
10.3.1 Performance Endpoint Analysis 
Although not a randomized study, each subject dialysis session will be performed using either 
the test needle or a control needle. The sites are instructed to perform 3 control sessions first and 
then 6 test sessions per enrolled subject, and in the case that a site deviates from this order, 
performance measure will be analyzed based on the needle used. Assuming there will be a 20% 
rate of attrition/drop-out, the remaining 18 subjects would contribute 108 test and 54 control 
sessions. Data will be pooled by session type (test vs. control) from all sites  (no by-site analyses 
are planned). 
The primary performance analysis will test the non-inferiority hypothesis as a difference of 
proportions between the test and control groups using a one-sided Farrington-Manning Score 
Test at a significance level of a=0.025. 
Additionally, the primary performance measure will be analyzed on the subject-level (utilizing a 
non-inferiority margin of 0.05) by testing the difference in mean success rates per subject across 
treatment groups using a one-sided paired t-test at a significance level of a=0.025.  
10.3.2 Safety Endpoint Analysis 
The incidence rates of adverse events (including those listed under the primary and secondary 
safety endpoints) will be calculated as the number of events per number of treatments as well as 
tallied per subject.  Adverse event rates will be summarized with 95% exact binomial confidence 
bounds for both the investigational and control groups.  
The adverse events of each group will also all be stratified by their (1) seriousness, (2) severity, 
(3) relatedness to device, (4) relatedness to procedure, and (5) anticipated status. 
Any events with onsets occurring between sessions will be associated with the group representing 
the device used at the last session. 
10.3.3 Usability and Additional Measures 
The results from the clinician and patient surveys (formatted on ordinal scaling) will each be 
summarized using the 5-point Likert scoring system (e.g., 5=strongly agree, 4=agree, 3=neither 
agree or disagree, 2=disagree, 1=strongly disagree) to represent user responses on a symmetric 
range, with overall item scores to represent usability measures.  The usability of the V Needle 
will be assessed from the clinician and patient survey scores submitted for the needle device used 
at the end of each session.  This will be done using a Mann-Whitney-Wilcoxon (MWW) test, 
which will assess differences in mean ranks of clinician/patient survey scores given to the V 
Needle and control devices, as applicable. 
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The following definitions are used for dialysis machine alarms: 
True Alarm:  Alarm was appropriate because clinician action was required beyond resetting the 
alarm (e.g., venous needle dislodgement, significant needle movement, infiltration, tape failure), 
and/or V Needle footplate opened appropriately. 
False Alarm:  No clinician action was required beyond resetting the alarm, and/or V Needle 
footplate opened inappropriately. 
The following definitions will be used for the footplate opening: 
Appropriate footplate opening:  Footplate opening due to a VND or infiltration and/or needle 
movement, tape failure, or other condition that can potentially lead to a VND or infiltration.   
Inappropriate footplate opening:  Footplate opening that is not due to a VND or infiltration 
and/or needle movement, tape failure, or other condition that can potentially lead to a VND or 
infiltration   
10.4 Other Statisical Considerations 
10.4.1 General/Summary Metrics 
Simple descriptive statistics will be displayed for all relevant variables collected under the study, 
and be presented on the session-level (between-subject), with the exception of the additional 
analysis of the primary performance measure which will be done on the individual-level (within-
subject). 
Continuous variables will display number of observations/counts measured, mean, standard 
deviation, median, min/max, Q1/Q3, and 95% confidence intervals where appropriate;  categorical 
variables will display frequency counts and percentages. 
These variables will include but are not limited to the following: 
• Subject demographics (including age, gender, weight, height, etc.) 
• Medical history characteristics (including concomitant medication, duration in which 
subject was diagnosed with renal disease, any concurrent ailmnets, etc.) 
 
Unless otherwise specified, all p-values will be considered significant at a=0.05 if tests are two-
sided and a=0.025 if tests are one-sided. 
10.4.2 Handling of Missing Data 
All practical monitoring and follow-up steps will be taken to ensure complete and accurate data 
collection. All analyses will be based on available data only; no imputation for missing data is 
planned. 

     
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11 Regulatory, Ethical, and Study Oversight Considerations 
11.1 Informed Consent Process 
11.1.1 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. 
11.1.2 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 will be asked to read and review 
the document. The investigator will explain the research study to the participant and answer any 
questions that may arise. A verbal explanation will be provided in terms suited to the 
participant’s comprehension of the purposes, procedures, and potential risks of the study and of 
their rights as research participants.  Participants will have the opportunity to carefully review 
the written consent form and ask questions prior to signing. The participants should have the 
opportunity to discuss the study with their family or surrogates or think about it prior to agreeing 
to participate. The participant will sign the informed consent document prior to any procedures 
being done specifically for the study. Participants 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 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.  
11.2 Study Discontinuation and Closure 
This study may be temporarily suspended or prematurely terminated if there is sufficient 
reasonable cause.  Written notification, documenting the reason for study suspension or 
termination, will be provided by the suspending or terminating party to the investigator, funding 
agency, and regulatory authorities.  If the study is prematurely terminated or suspended, the 
Principal Investigator (PI) will promptly inform study participants and the Institutional Review 
Board (IRB) and will provide the reason(s) for the termination or suspension.  Study participants 
will be contacted, as applicable, and be informed of changes to study visit schedule. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• Determination of unexpected, significant, or unacceptable risk to participants 
• Demonstration of efficacy that would warrant stopping 
• Insufficient compliance to protocol requirements 
• Data that are not sufficiently complete and/or evaluable 
• Determination that the primary endpoint has been met 

     
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• Determination of futility 
Study may resume once concerns about safety, protocol compliance, and data quality are 
addressed, and satisfy the sponsor, IRB and/or Food and Drug Administration (FDA). 
11.3 Confidentiality and Privacy 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, 
their staff, and the sponsor(s) and their interventions. This confidentiality is extended to cover 
testing of biological samples in addition to the clinical information relating to participants. 
Therefore, the study protocol, documentation, data, and all other information generated 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 the sponsor.  
All research activities will be conducted in as private a setting as possible. 
The study monitor, other authorized representatives of the sponsor, representatives of the 
Institutional Review Board (IRB), regulatory agencies or medical device company supplying 
study product may inspect all documents and records required to be maintained by the 
investigator, including but not limited to, medical records (office, clinic, or hospital) and 
pharmacy 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 
sponsor requirements. 
Study participant research data, which is for purposes of statistical analysis and scientific 
reporting, will be transmitted to and stored by the sponsor. This will not include the participant’s 
contact or identifying information. Rather, individual participants and their research data will be 
identified by a unique study identification number. The study data entry and study management 
systems used by clinical sites will be secured and password protected. At the end of the study, all 
study databases will be de-identified and archived by the study sponsor. 
11.4 Future Use of Stored Specimens and Data 
Data collected for this study will be analyzed and stored with the sponsor or with a clinical 
research organization retained by the sponsor.  No biological samples will be retained. 
11.5 Safety Oversight 
Safety oversight will be under the direction of Data Safety Monitoring Board (DSMB), which 
will consist of at least two clinicians and one statistician.  The DSMB shall be independent from 
the study conduct and free of conflict of interest, or measures should be in place to minimize 
perceived conflict of interest. The DSMB will operate under the rules of an approved charter that 
will be written by the sponsor and reviewed and approved by the DSMB.  

     
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11.6 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).  
Monitoring for this study will be performed by the sponsor or a clinical research organization. 
The sponsor will be provided copies of monitoring reports within 7 days of visit. Details of 
clinical site monitoring are documented in a Clinical Monitoring Plan (CMP). The CMP 
describes in detail who will conduct the monitoring, at what frequency monitoring will be done, 
at what level of detail monitoring will be performed, and the distribution of monitoring reports. 
11.7 Quality Assurance and Quality Control 
Quality control (QC) procedures will be implemented beginning with the data entry system and 
data QC checks that will be run on the database will be generated. Any missing data or data 
anomalies will be communicated to the site(s) for clarification/resolution. 
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. 
11.8 Data Handling and Record Keeping 
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.   
The sponsor and/or the sponsor’s representatives may be present during study visits to ensure 
that the device is appropriately administered and that the data is correctly collected.  The sponsor 
and/or their representative will not practice medicine and will not interact with the subjects 
outside the clinician’s supervision. 
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 will either be entered into an 
electronic case report form or collected in paper binders and transmitted via a scanner for 
collection, input into a central database, and analysis.  Clinical data (including adverse events 

     
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(AEs), concomitant medications, and expected adverse reactions data) and clinical laboratory 
data will be entered into study database.  No data that could be used to identify a patient will be 
transmitted. 
Study documents should be retained for a minimum of 2 years after the last approval of a 
marketing application in an International Conference on Harmonisation (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. 
11.9 Protocol Deviations 
A protocol deviation is any noncompliance with the clinical trial protocol, International 
Conference on Harmonisation 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.  
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 5 working days of identification of the protocol deviation, or within 5 working 
days of the scheduled protocol-required activity.  All protocol deviations must be addressed in 
study source documents.  Serious protocol deviations, which include misuses of the 
investigational device or deviations that endanger the study objectives, 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. Further details about 
the handling of protocol deviations will be included in the Standard Operating Procedures. 
11.10 Publication and Data Sharing Policy 
This study will be conducted in accordance with the following publication and data sharing 
policies and regulations: 
• National Institutes of Health (NIH) Public Access Policy, which ensures that the public 
has access to the published results of NIH funded research. It requires scientists to submit 
final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive 
PubMed Central upon acceptance for publication. 
• This study will comply with the NIH Data Sharing Policy and Policy on the 
Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials 
Registration and Results Information Submission rule. As such, this trial will be 

     
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registered at ClinicalTrials.gov, and results information from this trial will be submitted 
to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-
reviewed journals.  Data from this study may be requested from other researchers 2 years 
after the completion of the primary endpoint by contacting the sponsor. 
11.11 Conflict of Interest Policy 
The independence of this study from any actual or perceived influence, such as by the medical 
device industry, 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 study leadership in conjunction with the NIDDK has established 
policies and procedures for all study group members to disclose all conflicts of interest and will 
establish a mechanism for the management of all reported dualities of interest. 
12 Abbreviations 
AE 
Adverse Event 
AV 
Arteriovenous 
CFR 
Code of Federal Regulations 
CMP 
Clinical Monitoring Plan 
CRF 
Case Report Form 
DHHS 
Department of Health and Human Services 
DSMB 
Data Safety Monitoring Board 
EC 
Ethics Committee 
FDA 
Food and Drug Administration 
FDAAA Food and Drug Administration Amendments Act of 2007 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
HIPAA Health Insurance Portability and Accountability Act 
IB 
Investigator’s Brochure 
ICH 
International Conference on Harmonisation 
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigational Device Exemption 
INR 
International Normalized Ratio 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
KDIGO Kidney Disease Improving Global Outcomes 
MedDRA Medical Dictionary for Regulatory Activities 

     
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MOP 
Manual of Procedures 
NCT 
National Clinical Trial 
NIH 
National Institutes of Health 
NIH IC NIH Institute or Center 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SOA 
Schedule of Activities 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 
VND 
Venous Needle Dislodgment 
 
 
REVISION HISTORY 
Rev 
Summary of Changes 
Justification for Changes 
A 
None 
Initial Release 
B 
Added requirements for a staged study 
throughout the protocol. Updated inclusion and 
exclusion criteria. Updated the Schedule of 
activities (SOA) table. Updates to the risk-
benefit assessment section.  
Added a requirement for at least two different 
clinicians to evaluate the device for each 
patient.  
Added requirements for actions related to 
SADEs. 
Added requirements for the the Final Study 
Visit.  
Added additional requirements for the DSMB. 
Added additional performance measures.  
All Rev B updates were made 
based on requirements 
agreed on between Hemotek 
Medical and the FDA during 
the interactive IDE 
submission review. Rev B 
represents the FDA IDE 
approved version as of June 
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C 
Added requirements for patient hemolysis 
testing throughout the protocol under specified 
conditions. Updated a clerical error with the 
numbering within the exclusion criteria. Added 
episodes of partial and complete needle 
dislodgment to the additional performance 
measures. Added the expected success rate for 
both devices (98%). This was inadvertently not 
added to Rev A. 
Rev C updates were made to 
satisfy specific requirements 
specified in the “Study 
Design Considerations” 
section of the FDA IDE 
approval letter dated, June 
23rd, 2022. 
D 
Changed patient stipend to $50 payment per 
visit. 
Requested by study site. 
E 
Updated exclusion criteria lists, reimbursement 
approach (removed gift card) and clarified 
statistical sample size justification language 
Updates were made based 
on suggested ‘Additional 
Considerations’ list from FDA 
IDE, IDE supplement and first 
5-day notice responses