A Prospective, Randomized, PICC Asymptomatic Thrombosis Study: A Pilot Study
Phase: NA
Conditions: Peripheral ICC
Sponsor: Access Vascular Inc

A Prospective, Randomized PICC Asymptomatic Thrombosis Study 
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Title of Protocol:  A Prospective, Randomized, PICC Asymptomatic Thrombosis Study: A Pilot Study 
Version: C 
Date: 28Apr2021 
Date and Version of Previous Protocol: Version A; 31Aug2020: Version B; 26Oct2020 
Sponsor Name and Address: 
Access Vascular, Inc 
175 Middlesex Turnpike 
Suite 1A 
Bedford, MA 01730 
Investigational and Comparator Product(s): 
4 French Single Lumen: 
HydroPICC 
  
Protocol Author(s):  
 
 
NCT#04920929 

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3. CONTENTS  
Contents 
1. 
Signatures .............................................................................................................................................. 2 
1.1. 
Principal Investigator Signature Page ........................................................................................... 2 
2. 
Summary of Changes Table .................................................................................................................. 3 
3. 
CONTENTS .......................................................................................................................................... 5 
4. 
Protocol Synopsis .................................................................................................................................. 6 
5. 
Introduction ........................................................................................................................................... 9 
6. 
Study Rationale ................................................................................................................................... 11 
7. 
Study Objective (s) and Endpoints ...................................................................................................... 11 
8. 
Study Design ....................................................................................................................................... 12 
9. 
Study Methods and Measurements ..................................................................................................... 13 
10. Subject Selection ................................................................................................................................. 15 
11. Discontinued Subjects ......................................................................................................................... 17 
12. Study Treatment .................................................................................................................................. 17 
13. Study Procedures ................................................................................................................................ 19 
14. Evaluations by Visit ............................................................................................................................ 20 
15. Adverse Event Reporting .................................................................................................................... 21 
16. Statistical Design ................................................................................................................................ 25 
17. Data Management ............................................................................................................................... 26 
18. Sponsor and Monitor Responsibilities ................................................................................................ 26 
19. Administrative, Ethical, Regulatory Considerations ........................................................................... 27 
19.1. Statement of Compliance ............................................................................................................ 27 
19.2. Informed Consent Forms (ICF)................................................................................................... 27 
19.3. Publication Policy of Study Data ................................................................................................ 27 
19.4. End of Study ............................................................................................................................... 28 
19.5. Investigator Responsibilities ....................................................................................................... 28 
20. References .......................................................................................................................................... 29 
 
 
 

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5. Introduction 
5.1. Background 
Access Vascular has developed a novel, bulk-hydrophilic catheter material represents a fundamental shift 
in material technology. Catheters used for vascular access are commonly prepared from polyurethanes or 
silicones that provide flexibility, durability, and strength (Renner, 1998), (JM, 1995); however, these 
polymeric materials are hydrophobic and therefore susceptible to non-specific protein adsorption (Jordon 
SW, 2007), (Tal MG, 2008).  Access Vascular has developed a 
 
hydrogel material PICC line used to access the central venous system via a peripheral vein.  Hydrogels 
have found use in many different medical applications due to their high tolerability. As a result of several 
factors, including a high-water content and neutral surface charge, Access Vascular’s material may mask 
the catheter from the body significantly more effectively than traditional catheters, resulting in a 
significantly lower rate of thrombosis. 
 
 
 
 
 
 
The study purpose is to perform a preliminary evaluation of the Hydrogel technology to confirm the 
performance of the catheter, including evaluating thrombosis incidence
 
by using UltraSound technology in-vivo.  The secondary objective of this study 
is to evaluate the symptomatic thrombosis incidence rate in the two groups by using ultrasound technology.  
 
   
 
5.2. Disease and Medical Condition State 
Venous catheters are used to enable intravenous access for delivery of therapeutics such as antibiotics, 
chemotherapy, or parenteral nutrition, and for other applications such as blood draws. In the US, 
approximately 500 million procedures involving venous catheters are performed each year (McGee, 
2003), (O'Grady, et al., 2011), (Kornbau, Lee, Hughes, & Firstenberg, 2015).  
Thrombosis is the formation and accumulation of blood platelets inside a blood vessel.  There were many 
doctors who had theories about thrombosis, but it was through the works of Rudolf Virchow who 
described 3 factors that contribute to the development of venous thrombosis: hypercoagulability, statis of 
blood flow, and endothelial injury (Bagot & Arya, 2008).  When the body detects a potential threat to a 
blood vessel, such as blood vessel injury or a foreign object, one of the body’s responses is to trigger the 
clumping of platelets against the perceived threat, creating blood clots. In most situations, this reaction is 
vital to the organism’s survival, as the clumping prevents further blood loss or neutralizes a threatening 
foreign object. However, this response can be harmful in the case of venous access, since the body 
interprets the catheter as a foreign object and triggers clotting against the catheter. 
 
Several factors can contribute to the formation of thrombus, including, but not limited to, patient disease 
states inducing elevated systemic prothrombotic states (Van Rooden, 2005), peripheral versus central 
insertion (Fallouh, 2015), catheter tip malposition (Luciani, 2001), ratio of catheter size to vein diameter 
(O’Brien, 2013), catheter and/or infusate composition (Caroline Berube, 2017).  Although symptomatic 
line-related thrombosis incidence rates for PICCs range between 3-20% (Zochios, 2014), (Abdullah, 
2005), the total rate of upper extremity thrombosis related to the insertion of PICC devices is much 
higher, with one study measuring 38.5% of patients experiencing a UEVT, and some patient populations 
at higher risk (i.e. cancer) reaching rates as high as 60% (Luciani, 2001).  Although asymptomatic, UEVT 
has been associated with elevated rates of more serious adverse events such as pulmonary embolism and 
catheter-related sepsis.  

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There is a lack of research in regards to adult asymptomatic thrombosis (Pinelli & Balsorano, 2019).  The 
current asymptomatic research study is from the pediatric population where they found a high rate of 
asymptomatic catheter-related thrombosis (22%) in pediatric patients needing central venous catheters 
(Pinelli & Balsorano, 2019).   
 
The terminology also needs to be defined clearly because there is some confusion.  In a study conducted 
by Baskin et al., they referred to asymptomatic thrombosis as “fibrin sheath”.  Other terminology used is 
also “pericatheter thrombosis” and “pericatheter thrombotic apposition” (Pinelli & Balsorano, 2019).  We 
must be clear about the definition for this study.  In this protocol, we are looking for asymptomatic 
thrombosis using ultrasound technology.  This specifically means we are looking for PICCs with 
echogenic mass in or on the lumen, but no limb swelling, tenderness, or any symptomatic issues. 
 
More recently, in 2020, there was a study published on Chinese cancer patients using ultrasound and 
looking at asymptomatic venous thrombosis.  In this study by Wang et. al, they were able to find that the 
incidences of PICC related upper limb asymptomatic thrombosis was 48.82%, and the median to observe 
these thrombi was 3 days.  Within 24 hour of PICC insertion, there were 37.1% of patients with 
asymptomatic thrombosis, and within 1 week, that rate jumped to 85.49% (Wang, et al., 2020).  They 
showed that asymptomatic thrombosis can occur at an early stage.  Asymptomatic thrombosis is the way 
for some bodies to adapt to the trauma of PICC insertion.  If this can be detected earlier, then patients will 
be treated appropriately, and veins for future vascular access needs can be saved.   
 
As a result of thrombus related complications, catheter manufacturers have commercialized products 
focused on addressing these complications. Nearly all venous catheters are made from polyurethane, and 
several manufacturers, including the market leader, continue to sell standard, undifferentiated 
polyurethane catheters. Some companies have added anti-microbial coatings to their devices to provide 
anti-infective ability. Others have incorporated additives which attempt to mask the device from the body. 
While somewhat effective, these catheters are nonetheless primarily made of polyurethane and silicone.  
Although little difference exists in complications rates between the two materials (Seckold, 2015), both 
materials remain susceptible to the thrombus related complications described above. 
 
5.3. Overview of Non-Clinical Studies 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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5.4. Overview of Clinical Studies 
No clinical studies have been conducted with the current HydroPICC. 
6. Study Rationale 
6.1. Risk/Benefit Assessment 
The current products in this study are FDA 510k cleared.  The HydroPICC will be referred to as the 
investigational product for the purposes of this protocol.  There are no study risks associated with the use 
of the HydroPICC or the competitor PICC.  The benefit would be to analyze if a new material in this 
space would have better outcomes for patients who are in need of this type of medical device. 
Though rates of symptomatic thrombosis vary from 3-23% (Chin, Zimmerman, & Grant, 2005), rates of 
asymptomatic venous thrombosis have been reported as much higher at 48% (Wang, et al., 2020).  This 
study will assess the rate and severity of asymptomatic upper extremity venous thrombosis associated 
with the use of Access Vascular’s FDA-cleared HydroPICC as compared to a competitor device.   
 
7. Study Objective (s) and Endpoints 
The study purpose is to take a preliminary look at the Hydrogel technology to examine the asymptomatic 
thrombosis incidents 
by using Ultrasound 
technology in-vivo. 
7.1. Primary Objective and Endpoints 
The primary purpose is to examine the incidents of early asymptomatic thrombosis between the 
HydroPICC arm and the comparison arm. 
 
By using ultrasound technology, the site will measure early incidents of all asymptomatic thrombosis 
inclusive of superficial thrombophlebitis (SVT) and deep venous thrombosis (DVT).  Subjects will be 
requested to have the PICC line scanned at 7 days (± 5 days), and at any unscheduled visit where a 
symptomatic SVT or DVT is suspected. 
The ultrasound evaluation will be classified as (1) without thrombosis or (2) with limited (~2-4mm), (3) 
large (~4 mm), or (4) occlusive thrombosis, as compared to baseline.  Please see the ultrasound section 
below for more details. 
 
7.2. Secondary Objective and Endpoints 
The secondary objective of this study is to evaluate the symptomatic thrombosis rate in the two groups by 
using ultrasound technology.      
 
By using ultrasound technology, the site will measure all subjects to look for incidents of symptomatic 
thrombosis.  Subjects will be requested to have the PICC line scanned at 7 days (±5 days), 14 days (±7 
days and at any unscheduled visit where a DVT is suspected. 
 

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The ultrasound evaluation will be classified as (1) without thrombosis or (2) with limited (~2-4mm), (3) 
large (~4 mm), or (4) occlusive thrombosis, as compared to baseline.  Please see the ultrasound section 
below for more details. 
 
7.3. Other Objectives and Endpoints 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
8. Study Design 
This is a single-site, pilot, nonblinded randomized controlled performance evaluation to compare two 
brands of commercially-available single lumen PICC lines.  This is a postmarket clinical evaluation and 
not a statistically powered study.  
 
8.1. Study Overview 
This post market clinical evaluation is a prospective, randomized post-market assessment. Each eligible 
subject will receive a single lumen PICC device and will be placed per the manufacturer’s IFU and in 
accordance with institutional policy.  
 
 
 
 
  
  
Per institution policy, due to the fact that the HydroPICC is not a standard of care device, the patient will 
be consented prior to insertion.  This consent will follow the institution’s standard of care policies. 
 
 any patient receiving a single lumen PICC 
will be approached to join this study.  After the patient consents, and the site reviews the inclusion 
criteria, the subject can be randomized. 
 
Screening data will be reviewed to determine subject eligibility.  Subjects who meet all inclusion criteria 
and none of the exclusion criteria will be entered into the study.  There is an exclusion criteria which 
requires an ultrasound, and a subject can still be screen failed at the time of insertion. 
 
The following treatments will be used: 
 
AVI device: Access Vascular HydroPICC Single Lumen PICC 
Comparator device:  
 Single Lumen PICC 
Vein:  Preference is Basilic Vein followed by Brachial Vein, then Cephalic Vein 
 
Once a subject is inserted with a PICC line, they are considered enrolled. 
 

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Total duration of subject participation will be the duration for which the catheter is indwelling in the 
patient up to 16 days. The total study duration is expected to not exceed 23 days, including procedural 
pre-screen.  Insertion of the PICCs will be prioritized with the following: Basilic vein then Brachial vein 
followed by Cephalic vein.  Diagnosis of both asymptomatic and symptomatic vein thrombosis will be 
established by Doppler ultrasound examination.  Examinations will be performed prior to device insertion 
to establish patient baselines.   
 
Ultrasound will be performed pre-insertion of the device, at 7 days post-insertion (±5 days) and 14 days 
(±7 days).  Data will be collected using a scale defined previously.  
 
9. Study Methods and Measurements 
9.1. Methods Used to Minimize Bias and Maximize Validity 
This study will be randomized using CONSORT guidelines stated below (www.consort-statement.org).  
The randomization will be conducted via sealed envelope.  The specific randomization will be discussed 
in further detail below. 
 
 

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10. Subject Selection 
10.1. 
Screening 
All subjects who are indicated for a medically necessary Single Lumen PICC line will be screened for 
eligibility for the study.   
 
10.2. 
Consent 
If the patient is interested in moving forward with this study, then they will sign the study informed 
consent.  Those who do not consent will be logged as “declined to participate” in the screening log.  
Those who consent will be screened by the site staff using the inclusion and exclusion criteria.   
10.3. 
Inclusion Criteria 
1) Patient is indicated for a medically necessary PICC for therapeutic delivery medication 
2) Patient is eligible to receive a single lumen PICC 
3) Patient is an adult prescribed a PICC line 
4) Patient’s expected duration of treatment requiring a PICC for a minimum of 16 days post device 
implantation 
5) Patient understands and is willing to comply with all study requirements and has voluntarily 
signed the Informed Consent Form (ICF). 
 
10.4. 
Exclusion Criteria 
1) Is pregnant, lactating, or is planning to become pregnant during the time of the study 
2) Has been previously enrolled in this post market clinical evaluation, or is participating in another 
clinical study that is contraindicative to the treatment or outcomes of this investigation 
3) Venous thrombosis in any portion of the vein to be catheterized 
4) Conditions that impede venous return from the extremity such as paralysis or lymphedema after 
mastectomy 
5) Orthopedic or neurological conditions affecting the extremity 
6) Anticipation or presence of dialysis grafts or other intraluminal devices, including pacemakers, 
within a month of patient enrollment start   
7) Patients who are on anticoagulation therapy prior to the study (10-14 days).  Note: (If patients are 
placed on anticoagulation (low dose) therapy while hospitalized, these patients are allowed.) 
8) Patient has relinquished control of care to a guardian and/or facility   
9) Patient has any significant medical or physical condition that, in the opinion of the PI, would 
make the subject unsuitable for participation in the post market clinical evaluation   
10) Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons 
 
10.5. 
Randomization 
After consent and review of the inclusion/exclusion criteria, the Investigator can assign a randomization 
prior to baseline ultrasound.  If during the ultrasound procedure, the subject meets an exclusion criterion, 
then this subject will be considered a screen fail.    
10.6. 
Screen Failures 
Any subject who signs an informed consent but fails to meet the required entry criteria is considered to be 
a Screen Failure. Screen Failure subjects will have their demographic information captured in the 
appropriate CRF with the reason for screen failure specified.  No other information will be collected or 
analyzed.  Since this is a pilot study, the analysis will be conducted on 10 subjects on each arm.  If a 

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11. Discontinued Subjects 
If a subject is unable to complete the study for any reason, then the investigator will use the screen failed 
randomization envelope to recruit for this discontinued subject.  Data from the discontinued subject will 
not be used for the per protocol analysis.  However, demographics will be used for the recruitment 
analysis.  Any subjects in section 12 described below will be replaced using the method mentioned in this 
paragraph. 
11.1. 
Early Discontinuation of Study Subject 
A subject may be discontinued at any time if the subject, the investigator, or the Sponsor feels that it is 
not in the subject’s best interest to continue.  The following is a list of possible reasons for 
discontinuation: 
• 
Subject withdrawal of consent 
• 
Subject is not compliant with study procedures 
• 
Protocol violation requiring discontinuation  
• 
Sponsor request for early termination of study 
• 
Positive pregnancy test (females) 
All subjects who discontinue should come in for an early discontinuation visit as soon as possible and 
then should be encouraged to complete all remaining scheduled visits and procedures. 
 
11.2. 
Lost to Follow-Up 
The site should document at least 3 attempts to contact the subject before a subject is considered lost to 
follow-up.  This will be documented in the end of study CRF. 
11.3. 
Investigator Withdrawal 
Investigators have the authority to withdraw a subject at any time, for any reason, specified or 
unspecified, and without prejudice.  The investigator is requested to provide a reason for subject 
withdrawals.  The reason for the subject’s withdrawal from the study will be specified in the subject’s 
source documents and recorded on the end of study CRF.    
 
11.4. 
Subject’s Withdrawal of Consent 
All subjects are free to withdraw from participation at any time, for any reason, specified or unspecified, 
and without prejudice. Reasonable attempts will be made by the investigator to provide a reason for 
subject withdrawals.  The reason for the subject’s withdrawal from the study will be specified in the 
subject’s source documents and recorded on the end of study CRF.    
 
11.5. 
Use of Data Following Withdrawal 
Data collected while the subject provided will be used for the overall analysis.  No data will be collected 
or analyzed from the date that the subject withdrew from the study. 
12. Study Treatment 
12.1. 
Method of Assigning Subjects to Treatment Groups 
The subjects will be randomized to the two different treatment groups.  A match and replace method will 
be used to ensure that screen failed randomized subjects will be replaced appropriately.  The 
randomization assignment methodology will be documented in the Statistical Analysis Plan.     
12.2. 
Blinding 
There is no blinding in this protocol. 
12.3. 
Description of HydroPICC  

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13. Study Procedures 
13.1. 
Demographics 
Demographic information will be recorded at Screening after a subject has signed the consent.  This will 
include, but not limited to: 
• 
Date of birth 
• 
Race 
• 
Ethnicity 
• 
Gender 
 
13.2. 
Medical History 
Relevant medical history, including history of current disease, other pertinent venous history, and 
information regarding underlying diseases will be recorded at Screening. 
 
13.3. 
Physical Examination 
A complete physical examination will be performed by either the investigator or a sub-investigator who is 
a physician at Visit 1.   Qualified staff (MD, NP, RN, and PA) may complete the abbreviated physical 
exam at all other visits.  New abnormal physical exam findings must be documented and will be followed 
by a physician or other qualified staff at the next scheduled visit. 
13.4. 
Vital Signs 
Body temperature, blood pressure, Oxygen levels, heart rate and respirations will be performed.  Blood 
pressure is only to be performed in the supine position on the non-treatment appendage in the study.  
  
13.5. 
Concomitant Medications 
All concurrent therapies will be documented at Screening, at follow up visits, and at early termination 
when applicable.  Dose, route, unit frequency of administration, and indication for administration and 
dates of medication will be captured. 
 
13.6. 
Clinical Laboratory Measurements 
13.6.1. Laboratory Safety Measurements 
Safety laboratory tests for this study [e.g. chemistry, hematology, coagulation (for applicable 
subjects), and urinalysis] are to be performed by the local institution per their standard of care.   
 
13.6.2. Pregnancy Test 
A urine or serum pregnancy test will be obtained from female subjects who are of childbearing 
age prior to their participation in the study.  If a positive test returns, they are to be excluded.   
 
All subjects will be urged to use birth control during the length of the study, however, if a subject 
does become pregnant during the length of the study, this will be noted, and data can continue to 
be collected if the Investigator deems it safe.  All pregnancy related adverse events will be 
collected, but will be classified as pregnancy related. 
 
13.7. 
Ultrasound Measurements 
Ultrasound methodology:  The patient will be placed supine.  Their palm will face upward with 
their arm abducted at 90 ̊ to conduct an ultrasound scan of the PICC line.  
 
Ultrasonography will be performed on the vein that the PICC line is inserted. The vein will be 
scanned axially and transversely in two distinct sections.  The first section is from insertion to the 
axillary junction.  The second section is from the axillary junction to the superior vena cava 

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(SVC).  The technician will pay particular attention to 2 cm above the insertion site, and at 10 cm 
above the insertion site as these will be specific data points to be recorded.  The form used will 
have a picture of the vein and the technician can note where thrombosis was found.  They will 
then measure the size of the thrombosis and note the approximate location in the form.    
 
The diagnostic criteria will be based on any of the three US signs: (a) lack of normal vein 
compressibility, (b) lack of color signal from the vessel on the color Doppler scan, and (c) lack of 
signal from the vessel on the spectral Doppler scan.  If technical problems or anatomical barriers 
hamper visualization, findings from the ultrasonographic screening will be considered 
indeterminate and appropriately recorded.   
 
Based on ultrasound evaluation, veins will be classified as (1) without thrombosis or (2) with 
limited (2 to 4 mm), (3) large (~4 mm), or (4) occlusive thrombosis, as compared to baseline.   
 
The person reading the ultrasound will use a data collection form to review the classification of 
the veins.  The length and/or the depth of the thrombosis will be used to assess the classification.  
For example, if a thrombosis is 5mm long, but does not fully occlude the vessel, then it would be 
classified as a (3) large.  However, if a thrombosis is 5mm long AND occludes the vessel, then it 
would be classified as a (4) occlusive thrombosis.  The primary investigator will be responsible 
for confirming the classifications. 
 
 
 
Image of veins from: (Chin, Zimmerman, & Grant, 2005) 
14. Evaluations by Visit 
14.1. 
Screening Visit (Visit 1) 
1. Assign the subject a unique screening number. 
2. Perform informed consent process; subjects to sign and date the Informed Consent Form. 
3. Record demographics data. 

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4. Record medical history, including a history of condition(s) requiring chemotherapy or antibiotics, 
diagnosis date, and prior treatments related to the relevant condition(s). 
5. Record baseline labs, if available. 
6. Perform a complete physical examination. 
7. Perform and record vital signs. 
8. Schedule subject for Procedure visit in no more than 5 days 
9. Randomize the subject 
 
14.2. 
Surgical Visit- (Visit 2) 
1. Perform and record vital signs. 
2. Record labs, if available. 
3. Conduct Ultrasound prior to insertion of the assigned PICC.  Screen fail if necessary. 
4. Insert device per assigned randomization, IFU, and institutional procedures. 
5. Confirm patient entry into study. 
6. Take picture of insertion site. 
7. Record adverse events (if any). 
 
14.3. 
Follow Up Visit- (Visit 3) (7 days post placement ± 5 days) 
1. Perform and record vital signs. 
2. Record Adverse Events (if any). 
3. Record changes to concomitant medications (if any). 
4. Record labs, if available. 
5. Conduct ultrasound assessment of treatment extremity. 
6. Take picture of insertion site. 
 
14.4. 
Follow Up Visit- (Visit 4) (14 days post placement ± 7 days)/ MUST be at least 4 
days after the Visit 3 
7. Perform and record vital signs. 
8. Record Adverse Events (if any). 
9. Record changes to concomitant medications (if any). 
10. Record labs, if available. 
11. Conduct ultrasound assessment of treatment extremity. 
12. Take picture of insertion site. 
13. Complete the end of study CRF.  Indicate reason for end of study (completion of study, therapy, or 
otherwise).   
 
14.5. 
Unscheduled Visit(s) 
1. Perform and record vital signs. 
2. Record Adverse Events (if any). 
3. Record changes to concomitant medications. 
4. Record labs, if available. 
5. Conduct ultrasound assessment of treatment extremity. 
6. Take picture of insertion site. 
7. Remove or treat the PICC line per IFU and institutional protocols if necessary.  
8. If a subject is discontinued from the study due to a Serious Adverse Device Effect, the institution 
should notify their IRB per the IRB reporting requirements.   
 
15. Adverse Event Reporting 

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These definitions are for the purposes of this post market clinical evaluation only.  Medical Device 
Reporting (MDR) will be conducted using the normal AVI definitions for reporting to the FDA.  We will 
follow 
.  
Adverse Event (AE) (ISO 14155:2020): untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, 
whether or not related to the investigational medical device and whether anticipated or unanticipated.   
Note 1: This definition includes events related to the investigational medical device or the comparator.  
Note 2: This definition includes events related to the procedures involved.  
Note 3: For users or other persons, this definition is restricted to events related to the use of investigational medical devices or 
comparators. 
Adverse Device Effect (ADE) (ISO 14155:2020): is an adverse event that is related to the use of an 
investigational medical device.  
Note 1: 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.  
Note 2: This definition includes any event resulting from use error or from intentional misuse of the investigational medical 
device.  
Note 3: This includes “comparator” if the comparator is a medical device. 
Comparator: medical device, therapy (e.g. active treatment, normal clinical practice), placebo or no treatment, used in the control group in a 
clinical investigation. 
 
Serious Adverse Event (ISO 14155:2020):    
A Serious Adverse Event (SAE) is an adverse event that: 
a) Led to death, 
b) Led to serious deterioration in the health of the subject, users, or other persons as defined by 
one or more of the following:1) A life-threatening illness or injury, or 
2) A permanent impairment of a body structure or a body function including chronic diseases, or 
3) In-patient or prolonged hospitalization, or 
4) Medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function, 
c) Led to fetal distress, fetal death or a congenital abnormality or birth defect including physical or mental 
impairment 
Note: Planned hospitalization for a pre-existing condition, or a procedure required by the study protocol, without serious 
deterioration in health, is not considered a serious adverse event. 
 
Serious Adverse Device Effect (SADE):  A Serious Adverse Device Effect (SADE) is an adverse device 
effect that has resulted in any of the consequences characteristic of a serious adverse event 
 
AE Severity 
The National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 
should be used to assess and grade AE severity, including laboratory abnormalities judged to be clinically 
significant (US Department of Health and Human Services, 2017). The modified criteria can be found in 
the study manual   If the experience is not covered in the modified criteria, the guidelines shown in  
Table 1 below should be used to grade severity.  It should be pointed out that the term “severe” is a 
measure of intensity and that a severe AE is not necessarily serious. 
 
Table 1.  AE Severity Grading 

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Severity (Toxicity Grade) 
Description 
Mild (1) 
Asymptomatic or mild symptoms; clinical or diagnostic observations 
only; intervention not indicated. 
Moderate (2) 
minimal, local or noninvasive intervention indicated; limiting age 
appropriate instrumental ADL*. 
Severe (3) 
Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; 
limiting self care ADL** 
Life-threatening (4) 
Life-threatening consequences; urgent intervention indicated. 
Death (5) 
Death related to AE 
Activities of Daily Living (ADL)  
*Instrumental ADL refer to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.  
**Self care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden. 
 
AE Relationship to Device 
The relationship of an AE to the study device should be assessed using the following the guidelines in 
Table 2. 
 
Table 2.  AE Relationship to Study Device 
Relationship 
to Device 
Comment 
Definitely 
Previously known hazard related to this class and type of device; or an event that 
follows a reasonable temporal sequence from implantation of the device; that follows 
a known or expected response pattern to the suspected device; that is confirmed by 
stopping and removal of the device; and that is not explained by any other reasonable 
hypothesis. 
Probably 
An event that follows a reasonable temporal sequence from implantation of the 
device; that follows a known or expected response pattern to the device; that is 
confirmed by stopping or removal of the device; and that is unlikely to be explained 
by the known characteristics of the subject’s clinical state or by other interventions. 
Possibly 
An event that follows a reasonable temporal sequence from implantation of the 
device; that follows a known or expected response pattern to that device; but that 
could readily have been produced by a number of other factors. 
Unrelated 
An event that can be determined with certainty to have no relationship to the study 
device. 
 
AE Relationship to Study Procedure 
The relationship of an AE to the study procedure should be assessed using the following the guidelines in 
Table 3. 
 
Table 3.  AE Relationship to Study Procedure 
Relationship 
to Device 
Comment 
Definitely 
Previously known hazard related to this procedure; or an event that follows a 
reasonable temporal sequence from the procedure; that follows a known or expected 
response pattern to the suspected procedure; that is confirmed by stopping the 
procedure; and that is not explained by any other reasonable hypothesis. 

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Probably 
An event that follows a reasonable temporal sequence from the procedure; that 
follows a known or expected response pattern to the procedure; that is confirmed by 
stopping the procedure; and that is unlikely to be explained by the known 
characteristics of the subject’s clinical state or by other interventions. 
Possibly 
An event that follows a reasonable temporal sequence from the procedure; that 
follows a known or expected response pattern to the procedure; but that could readily 
have been produced by a number of other factors. 
Unrelated 
An event that can be determined with certainty to have no relationship to the 
procedure. 
 
15.1. 
Device Deficiency 
A Device Deficiency (DD) is an inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, usability, safety or performance.  
Note 1: Device deficiencies includes malfunctions, use errors and inadequacy in the information supplied 
by the manufacturer including labelling.  
Note 2: This definition includes device deficiencies related to the investigational medical device (3.29) or 
the comparator 
 
15.2. 
Reporting Procedures 
AE of any kind and DD will be recorded in the applicable CRF and source notes. The collection 
of AE’s is started at the time of the procedure.   
 
The Investigator will evaluate all AE for seriousness, severity and relationship to the device and 
procedure.  The following reporting timelines should be followed for the AE/DD information to 
be submitted/entered into the CRF and reported to the Sponsor or designee: 
• 
ADE and DD – will be reported in a timely manner (within 3 working days of the 
investigator being informed about the event) 
• 
SAE, SADE and DD with potential to cause SADE – immediately (i.e. within 24 
hours of the investigator being informed about the event) 
To report:  Enter data into the EDC system.  This will generate an automated email to the clinical 
team.  If you do not have access to the EDC system, call Access Vascular at 
 
and/or email the clinical team at 
 
 
For ADE, SADE and DD, details of the product/procedure related to the event will be included 
and where applicable, pictures taken of the device. The deficient product should be retained for 
return to the sponsor via the return kits. Depending on the nature of the adverse event, the sponsor 
may request copies of the subject’s medical records, Imaging, Operative notes, as well as results 
of any relevant laboratory tests performed or other documentation related to the AE. If the subject 
was hospitalized, a copy of the discharge summary may be requested by the sponsor and should 
be forwarded as soon as it becomes available.  A narrative of these ADE, SADE, or DD may be 
required to provide a summary of the event. 
 
The Investigator and investigative site will also be responsible for required reporting to the site’s 
Institutional Review Board / Independent Ethics Committee (IRB/IEC) for all AEs, SAEs, and 
UADEs. 
 
Ongoing Adverse Events at Study Discontinuation 
At the time of data analysis (e.g., interim or final), an evaluation of ongoing events should take 
place and be listed as ongoing in the safety table. 

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16. Statistical Design 
 
16.1. 
General Considerations 
Study data will be made available in listings or electronic files as needed.  The study results will be 
reported in tabular form using descriptive statistics, confidence intervals, or statistical tests as indicated.  
 All summaries will be done by randomized treatment group.  Numeric descriptive statistics include the n, 
mean, standard deviation (SD), median, minimum value, and maximum value. These will be calculated 
for all numeric baseline data. Categorical summaries will show the number and percent of subjects in the 
levels associated with the variable summarized and the analysis performed. Percentages will be calculated 
based on the total number of subjects with non-missing data for the assessment. The denominator should 
be included for each summary to indicate the set of subjects being summarized.  
For any inferential analyses, a two-sided p-value of less than or equal to 0.05 will be considered 
statistically significant.   Any confidence intervals provided will be two-sided 95% intervals.  The 
primary effectiveness assessment is considered the primary analysis.  This study is not intended to 
support claims and the other statistical tests included are intended to assist with reporting, hence, no other 
adjustment for multiplicity will be used. 
 
 
   
 
16.2. 
Sample Size Justification 
This is a pilot study to see if the ultrasound endpoint is feasible for a larger study.  No power analysis was 
conducted for this study. 
16.3. 
Analysis Populations 
The primary analysis will be based on a Full Analysis Set (FAS) analysis population defined as those who 
were randomized and met all inclusion and exclusion criteria.  A Per-Protocol (PP) population will be 
completed that excludes subjects who have one or more major protocol deviations.  Major protocol 
deviations will be identified prior to locking the database for the final analysis and will include, but are 
not limited to, not receiving the randomized treatment, not completing the study, and not have met all 
inclusion and exclusion criteria.  Information for subjects not in the FAS population will be listed if 
available. 
 
16.4. 
Accountability and Baseline Data 
Study completion information including reasons for discontinuation and visits completion information 
will be summarized.  Baseline demographics, medical history, and BMI (kg/m2) will be summarized 
descriptively.    
 
16.5. 
Analyses 
16.5.1. Analysis of Primary Endpoint 
The primary endpoint will be summarized categorically based on the scale previously described regarding 
an ultrasound result of asymptomatic subject thrombosis severity. These results will be summarized by 
treatment group at each visit (pre-insertion, post-insertion, and at 7-day follow-up visit).  A Cochran-
Armitage trend test will be used to assess the null hypothesis that there is not trend associated with the 
treatment and the highest level of thrombosis. 

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Additionally, the presence of any asymptomatic thrombosis will be evaluated as a binary outcome and 
Fisher’s Exact test will be used to evaluate the null hypothesis that the rate of any thrombosis is 
homogeneous in the treatment arms. 
If COVID-19 subjects are identified in the study, the primary endpoint and any thrombosis outcomes will 
be summarized separately in those subjects. 
16.5.2. Analysis of Secondary Endpoint(s) 
The secondary endpoint of symptomatic thrombosis severity will be analyzed in the same manner as the 
primary endpoint.  
16.5.3. Analysis of Other Endpoint(s) 
Failure and safety endpoints will also be compared between the HydroPICC group and control group using 
Fisher’s exact tests.  
 
16.6. 
Adverse Event Analyses 
A listing of all individual AEs will be provided. Summary tables will be presented by system organ class 
based on the Medical Dictionary for Regulatory Activities (MedDRA Version 18.0 or higher) 
terminology list (preferred terms).  The number and percentage of subjects with one or more event will be 
summarized by treatment group along with the total number of events.  This summary will be provided 
for all AEs, SAEs, device-related AEs, and device-related SAEs.   
 
All SAEs will also have a detailed narrative provided.   
 
17. Data Management  
The data collected in the CRFs will be entered into a database.  The data will be subject to verification, 
validation and archiving according to the standard operating procedures of the Sponsor. The data will be 
analysed with reference to the analysis plan.  Any deviations from the planned analysis will be 
documented in the final study report. 
 
17.1. 
Confidentiality 
Data will be de-identified on forms and in the clinical database, and subjects will be identified only by a 
code or subject number. All information and data sent to sponsor or designee concerning patients or their 
participation in this study will be considered confidential, and confidentiality shall be observed by all 
parties involved at all times during the study. All data used in analysis and reports will be used without 
identifiable reference to the subject. All data will be secured against unauthorized access. The Investigator 
and investigative site will be responsible for compliance with all local privacy regulations (e.g., Health 
Insurance Portability and Accountability Act of 1996). 
 
18. Sponsor and Monitor Responsibilities 
Monitoring visits will be conducted by representatives of the Sponsor according to the study Clinical 
Monitoring Plan in compliance with U.S. CFR Title 21 Parts 50, 56, and 812 and ICH Guidelines for 
GCP (E6).    By signing this protocol, the Investigator grants permission to the Sponsor (or designee), and 
appropriate regulatory authorities to conduct on-site monitoring and/or auditing of all appropriate study 
documentation. 
 
The Sponsor will designate a monitor to conduct the appropriate site visits at the appropriate intervals. 
The post market clinical evaluation will be monitored to ensure that: the rights and wellbeing of the 
subjects are protected; the reported data are accurate, complete, and verifiable from the source documents; 
and the study is conducted in compliance with the currently approved protocol and amendment(s), if 

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applicable, with GCP regulations, and with applicable regulatory requirements.  Due to COVID, these 
monitoring visits may be conducted virtually/remotely.  The sponsor and institution will evaluate the best 
solution for monitoring, and the monitoring plan will provide details for multiple scenarios. 
 
The Sponsor or designee will record, report and analyse all protocol deviations.  The Sponsor will also 
ensure corrective and preventive actions are taken, including assessment of principal investigator 
disqualification criteria. 
 
Detailed monitoring requirements will be documented in the Clinical Monitoring Plan for this study. 
  
 
19. Administrative, Ethical, Regulatory Considerations 
19.1. 
Statement of Compliance 
This evaluation will not commence until the required approval/favorable opinion from the IRB or 
regulatory authority has been obtained. Any additional requirements imposed by the IRB or regulatory 
authority will be followed. 
 
In compliance with the Food and Drug Administration Amendments Act of 2007 (FDAAA), this study 
will be listed in www.clinicaltrials.gov. 
 
This post market clinical evaluation will be performed in compliance with the ethical principles of the 
Declaration of Helsinki: Clinical investigation of medical devices – Good Clinical Practice. 
 
19.2. 
Informed Consent Forms (ICF) 
Informed consent will be obtained in accordance with the Declaration of Helsinki, ICH GCP, US Code of 
Federal Regulations for Protection of Human Subjects (21 CFR 50.25[a,b], CFR 50.27, and CFR Part 56, 
Subpart A), the Health Insurance Portability and Accountability Act (HIPAA, if applicable), and local 
regulations.  As this is evaluation is assessing a commercially-available device per the cleared indication, 
informed consent will primarily confirm the subject’s willingness to provide their data and be 
randomized. 
 
The Investigator will prepare the informed consent form and provide it to the Sponsor or designee for 
approval prior to submission to the IRB.  The consent form generated by the Investigator must be 
acceptable to the Sponsor and be approved by the IRB.  The written consent document will embody the 
elements of informed consent as described in the applicable ICH and federal guidelines and will also 
comply with local regulations for a post market evaluation of a commercially-available device. The 
Investigator will send an IRB-approved copy of the Informed Consent Form to the Sponsor (or designee) 
for the study file. 
 
A properly executed, written, informed consent will be obtained from each subject prior to entering the 
subject into the trial.  Information should be given in both oral and written form and subjects (or their 
legal representatives) must be given ample opportunity to inquire about details of the study.  If a subject is 
unable to sign the ICF, a legal representative may sign for the subject.   A copy of the signed consent 
form will be given to the subject or legal representative of the subject and the original will be maintained 
with the subject’s records. 
 
19.3. 
Publication Policy of Study Data 
The preparation and submission for publication of manuscripts containing the study results shall be in 
accordance with a process determined by the Clinical Trial Agreements between the study Sponsor and 
participating institutions. The publication or presentation of any study results shall comply with all 

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applicable privacy laws, including, but not limited to the Health Insurance Portability and Accountability 
Act of 1996. 
 
19.4. 
End of Study 
Should circumstances arise which require the termination of the entire study prior to its planned 
completion (e.g., safety concerns) or circumstances arise which mean the end of the participation of an 
individual site (e.g., departure of Investigator, non-compliance), then this will be undertaken according to 
the SOPs of the Sponsor. 
 
 
19.5. 
Investigator Responsibilities 
By signing the Agreement of Investigator form, the Investigator agrees to: 
1. 
Conduct the study in accordance with the protocol and only make changes after notifying the 
Sponsor (or designee), except when to protect the safety, rights or welfare of subjects. 
2. 
Personally conduct or supervise the post market clinical evaluation (or investigation). 
3. 
Ensure that the requirements relating to obtaining informed consent and IRB review and approval 
meet federal guidelines, as stated in § 21 CFR, parts 50 and 56. 
4. 
Report to the Sponsor or designee any AEs that occur in the course of the study, in accordance 
with §21 CFR 812. 
5. 
Ensure that all associates, colleagues and employees assisting in the conduct of the study are 
informed about their obligations in meeting the above commitments. 
6. 
Maintain adequate and accurate records in accordance with §21 CFR 812 and to make those 
records available for inspection with the Sponsor (or designee). 
7. 
Ensure that an IRB that complies with the requirements of §21 CFR part 56 will be responsible for 
initial and continuing review and approval of the clinical study. 
8. 
Promptly report to the IRB and the Sponsor (or designee) all changes in the research activity and 
all unanticipated problems involving risks to subjects or others (to include amendments and safety 
reports). 
9. 
Seek IRB approval before any changes are made in the research study, except when necessary to 
eliminate hazards to the patients/subjects. 
10. Comply with all other requirements regarding the obligations of clinical investigators and all other 
pertinent requirements listed in § 21 CFR part 812. 
 
 
 

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