Prospective Observational Study of the Power PICC Family of Devices and Accessories
Conditions: Peripherally Inserted Central Catheter
Sponsor: Becton, Dickinson and Company

1 of 1 
 
 
Cover Page of study protocol 
 
COVER PAGE OF STUDY PROTOCOL 
 
Study title: 
Prospective Observational Study of the 
PowerPICC 
Family 
of 
Devices 
and 
Accessories 
 
Protocol number.:
MDS-19PICCEU01 
 
NCT number:
NCT04263649  
 
Protocol version and date:
v.1.0, 12-December 2019 
 

Protocol Number: MDS-19PICCEU01 
CONFIDENTIAL 
Version: 1.0 
Date:  12DEC2019 
Page 1 of 39 
TITLE PAGE 
Protocol Title: Prospective Observational Study of the Power PICC Family of Devices and 
Accessories 
Protocol Number:  MDS-19PICCEU01 
Version Number:  1.0 
Study Device:  Power PICC Family of Devices 
Study Type: Prospective, Observational, Multi-Center, Post-Market 
Short Title:  Power PICC Prospective Observational PMCF Study 
Acronym:  PICC PMCF 
Sponsor Name:  Becton Dickinson, & Company 
Legal Registered Address:  Bard Access Systems 
605 North 5600 West 
Salt Lake City, Utah 84116 
United States 
Sponsor Contact:   Audrey Lainesse, MSc, CCRA, PMP 
Senior Clinical Project Manager 
Global Clinical Development 
2555 Boul. Parc Technologique  
Québec, Québec 
G1P4S5 Canada 
t: 418.780.7781 
c: 418.929.8638 
audrey.lainesse@bd.com  
Regulatory Agency Identifier Number(s): TBD 
Approval Date:  12DEC2019 
Version History 
Version Number 
Date 
Type 
1.0 
12 December 2019
Original 

Protocol Number: MDS-19PICCEU01  
 
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PRINCIPAL INVESTIGATOR AGREEMENT PAGE 
 
 Investigator Responsibilities 
 
1. Prior to participation in this study, the Investigator or Institution must sign the Clinical 
Study Agreement (CSA) and obtain written approval from the appropriate Institutional 
Review Board (IRB)/Ethics Committee (EC). 
2. The Investigator must receive BD-sponsored training prior to site activation. The 
Investigator is responsible for ensuring that all Sub-Investigators and clinical staff are 
adequately trained prior to performing any data collection or study-related procedures.   
3. The Principal Investigator shall ensure that the study is conducted in accordance with the 
study protocol, any modifications as requested by the IRB/EC, the signed CSA, the 
ethical principles of the Declaration of Helsinki, Good Clinical Practice (ICH E6) / ISO 
14155),  EU MDR (Council Regulation 2017/745 of 5 April 2017), and applicable 
national/regional regulations and laws. 
4. If applicable, ensure that written informed consent is obtained from each participant prior 
to the conduct of any study activity, using the current IRB/EC approved Informed 
Consent Form. 
 
 
I have read and understand the contents of this study protocol. I agree to follow and abide by the 
requirements set forth in this document. I agree to conduct the trial in accordance with 
the study protocol, the signed Clinical Study Agreement, and Good Clinical Practice (GCP) as 
well as applicable ISO regulations (e.g., ISO 14155:2011E). I agree to participate in BD-
Sponsored training prior to performing any data collection or study-related procedures. 
 
 
Agreed to by (Investigator):  
  
_______________________________________________  
Printed Name – Investigator   
  
_______________________________________________  
Signature – Investigator  
 
_______________________________________________  
 Site Name and Number 
 
_______________________________________________  
Date  
 
 
 

Protocol Number: MDS-19PICCEU01  
 
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SUB-INVESTIGATOR AGREEMENT PAGE 
  
Sub-Investigator Responsibilities 
 
1. The Sub-Investigator must receive study specific training prior to performing any data 
collection or study-related procedures.   
2. The Sub-Investigator shall conduct the study in accordance with the study protocol, any 
modifications as requested by the IRB/EC, the signed CSA, the ethical principles of the 
Declaration of Helsinki, Good Clinical Practice (ICH E6) / ISO 14155), EU MDR 
(Council Regulation 2017/745 of 5 April 2017), and applicable national/regional 
regulations and laws. 
3. If applicable, ensure that written informed consent is obtained from participants prior to 
the conduct of any study activity, using the current IRB/EC approved Informed Consent 
Form. 
 
 
I have read and understand the contents of this study protocol. I agree to follow and abide by the 
requirements set forth in this document. I agree to conduct the trial in accordance with 
the study protocol, the signed Clinical Study Agreement, and Good Clinical Practice (GCP) as 
well as applicable ISO regulations (e.g., ISO 14155:2011E). I agree to participate in study-specific 
training prior to performing any data collection or study-related procedures. 
 
 
Agreed to by (Sub-Investigator):  
  
_______________________________________________  
Printed Name – Sub-Investigator   
  
_______________________________________________  
Signature – Sub-Investigator  
 
_______________________________________________  
 Site Name and Number 
 
_______________________________________________  
Date  
 
 
 
 
 

Protocol Number: MDS-19PICCEU01  
 
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TITLE PAGE .................................................................................................................................. 1 
Abbreviations .................................................................................................................................. 8 
1 
PROTOCOL SUMMARY ...................................................................................................... 9 
1.1 
Synopsis ........................................................................................................................... 9 
1.2 
Schedule of Activities .................................................................................................... 15 
2 
INTRODUCTION ................................................................................................................ 16 
2.1 
Background .................................................................................................................... 16 
2.2 
Rationale ......................................................................................................................... 16 
2.3 
Risk/Benefit Assessment ................................................................................................ 17 
2.3.1 
Risk Assessment ..................................................................................................... 17 
2.3.2 
Benefit Assessment ................................................................................................. 18 
2.3.3 
Overall Benefit: Risk Conclusion ........................................................................... 18 
3 
OBJECTIVES AND ENDPOINTS ...................................................................................... 18 
4 
STUDY DESIGN.................................................................................................................. 20 
4.1 
Overall Design ................................................................................................................ 20 
4.2 
Scientific Rationale for Study Design ............................................................................ 20 
4.2.1 
Participant Input into Design .................................................................................. 20 
4.3 
End of Study Definition ................................................................................................. 20 
5 
STUDY POPULATION ....................................................................................................... 20 
5.1 
Inclusion Criteria ............................................................................................................ 20 
5.2 
Exclusion Criteria ........................................................................................................... 21 
5.3 
Lifestyle Considerations ................................................................................................. 21 
5.4 
Screen Failures ............................................................................................................... 21 
6 
STUDY INTERVENTION ................................................................................................... 21 
6.1 
Investigational/Test Device ............................................................................................ 21 
6.2 
Control Device/Standard of Care ................................................................................... 23 
6.3 
Ancillary Devices/Products ............................................................................................ 23 
6.4 
Device Labeling ............................................................................................................. 23 
6.5 
Treatment Allocation and Measures to Minimize Bias .................................................. 23 
7 
STUDY PROCEDURES AND ASSESSMENTS ................................................................ 24 
7.1 
Screening and Enrollment .............................................................................................. 24 
7.2 
Medical History / Baseline Assessments ....................................................................... 24 

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7.3 
Index Procedure .............................................................................................................. 24 
7.3.1 
Procedure Data ........................................................................................................ 24 
7.3.2 
Ease of Insertion Procedure Survey ........................................................................ 25 
7.4 
Use and Maintenance Procedures .................................................................................. 25 
7.4.1 
Use and Maintenance Data ..................................................................................... 25 
7.5 
Device Removal Procedure ............................................................................................ 26 
7.5.1 
Device Removal Data ............................................................................................. 26 
8 
PARTICIPANT DISCONTINUATION/WITHDRAWAL.................................................. 26 
8.1 
Discontinuation/Withdrawal .......................................................................................... 26 
8.2 
Lost to Follow-Up .......................................................................................................... 26 
9 
ADVERSE EVENTS AND DEVICE DEFICIENCIES....................................................... 27 
9.1 
Definitions of Events ...................................................................................................... 27 
9.1.1 
Adverse Events (AEs) ............................................................................................. 27 
9.1.2 
Serious Adverse Events (SAEs) .............................................................................. 27 
9.1.3 
Adverse Device Effect (ADE) / Serious Adverse Device Effect (SADE) .............. 28 
9.1.4 
Unanticipated (Serious) Adverse Device Effect (UADE/USADE) ........................ 28 
9.2 
Severity of Adverse Events ............................................................................................ 28 
9.3 
Relationship of Adverse Event to Device(s)/Procedure ................................................. 29 
9.4 
Reporting of Events ........................................................................................................ 29 
9.5 
Safety Committees ......................................................................................................... 30 
9.6 
Device Deficiencies ........................................................................................................ 30 
10  STATISTICAL METHODS ................................................................................................. 30 
10.1  Overview of Study Design ............................................................................................. 30 
10.2  Sample Size Considerations ........................................................................................... 31 
10.3  Analysis Population ........................................................................................................ 31 
10.4  Primary Endpoint(s) ....................................................................................................... 31 
10.4.1  Safety ...................................................................................................................... 31 
10.4.2  Performance ............................................................................................................ 31 
10.5  Secondary Endpoint(s) ................................................................................................... 32 
10.6  Interim Analysis ............................................................................................................. 32 
11  DATA COLLECTION AND RECORD MAINTENANCE ................................................ 32 
11.1  Case Report Forms ......................................................................................................... 32 

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11.2  Source Documentation ................................................................................................... 33 
11.3  Data Management .......................................................................................................... 33 
11.4  Record Retention ............................................................................................................ 33 
12  QUALITY CONTROL AND ASSURANCE ...................................................................... 33 
12.1  Control of Study Products .............................................................................................. 33 
12.2  Monitoring ...................................................................................................................... 33 
12.3  Audits and Inspections ................................................................................................... 34 
12.4  Protocol Deviations ........................................................................................................ 34 
13  ADMINISTRATIVE REQUIREMENTS ............................................................................ 35 
13.1  Investigator and Site Selection ....................................................................................... 35 
13.2  Training .......................................................................................................................... 35 
13.3  Required Documents ...................................................................................................... 35 
13.4  Publication Policy .......................................................................................................... 36 
13.5  Study Registration .......................................................................................................... 36 
13.6  Termination of Study ..................................................................................................... 36 
14  ETHICAL AND REGULATORY CONSIDERATIONS .................................................... 37 
14.1  IRB/EC Approval ........................................................................................................... 37 
14.2  Informed Consent and Confidentiality ........................................................................... 37 
14.2.1  Confidentiality ........................................................................................................ 37 
14.3  Regulatory Status ........................................................................................................... 38 
14.4  Statement of Compliance ............................................................................................... 38 
15  REFERENCES ..................................................................................................................... 39 
 
 
 

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Abbreviations 
 
AE 
Adverse event 
Bard 
C. R. Bard, Inc.
BD 
Becton Dickinson and Company
CE 
Certification mark
CFR 
Code of Federal Regulations
CI 
Confidence Interval
CRA 
Clinical Research Associate
CRF 
Case Report/Record Form
CRO 
Contract Research Organization
CT 
Computed tomography
CVC 
Central venous catheter
CVP 
Central venous pressure
EU 
European Union
FDA 
Food and Drug Administration
FT 
Fit for Veins 
GCP 
Good Clinical Practice
HF 
High Flow 
HIPAA  
Health Insurance Portability and Accountability Act
ICH 
International Council for on Harmonisation of Technical 
Requirements for Pharmaceuticals for Human Use
IV 
Intravenous 
IRB/EC 
Institutional or Independent Review Board/Ethics Committee 
PICC 
Peripherally Inserted Central Catheter
PIV 
Peripheral intravenous catheter
SAE 
Serious Adverse Event
SD 
Standard Deviation
SoA 
Schedule of Activities
SOP 
Standard Operating Procedure
SV 
Small Veins 
TMF 
Trial Master File
VAD 
Vascular access device
VT 
Venous Thrombosis
 
 
 

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1 
PROTOCOL SUMMARY 
 
1.1 Synopsis 
 
Protocol Title 
Prospective Observational Study of the Power PICC Family of Devices 
and Accessories 
Short Title 
Power PICC Prospective Observational PMCF Study 
Rationale 
This study is designed to collect prospective data related to the safety 
and performance of the Power PICC family of devices and its 
accessories in a real-world setting.  Only patients who require one of the 
study devices may be considered for enrollment.  The choice of device 
required for individual patients is left to the discretion of the clinician. 
Objectives and Endpoints* 
*Note: Clinical endpoints are 
gathered from information 
collected as part of the 
participants’ routine care. No 
study specific procedures will 
be performed. 
 
Objective(s) 
Endpoint(s) 
Primary Safety 
 To assess the incidence of 
symptomatic venous thrombosis 
(VT) in patients with 
PowerPICC, PowerPICC 
SOLO2, and PowerGroshong 
PICC devices (PICCs) used for 
both short- and long-term venous 
access. 
Primary Safety 
 Incidence defined as any new 
occurrence of symptomatic VT 
defined by thrombus presence 
confirmed by ultrasonography or 
other imaging 
Primary Performance 
 To assess the rate of therapy 
completion in PICCs used for 
both short- and long-term 
therapy 
Primary Performance 
 Percent of PICCs that remain in 
place through the required 
therapy time period (completion 
of therapy) (success/failure) 
Secondary Safety 
 To assess the incidence of select 
complications in patients with 
PICCs used for both short- and 
long-term venous access while 
in-situ and during insertion. 
 
Secondary Safety 
 Incidence defined as any new 
occurrence of: 
o Phlebitis 
o Extravasation 
o Local infection  
o Bloodstream infection  
o Accidental dislodgement 
o Vessel laceration  
o Vessel perforation 

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Protocol Title 
Prospective Observational Study of the Power PICC Family of Devices 
and Accessories 
Secondary Performance 
 To assess the incidence of select 
performance measures in PICCs 
used for both short- and long-
term therapy 
Secondary Performance 
 Percent of patent catheters 
(number of functional catheters 
through therapy/total number of 
catheters) 
 Percent of placement success in 
single insertion attempt 
(placement success defined as 
single insertion attempt, proper 
tip location, and patent catheter) 
(successful placement / total 
insertions)  
 Usability  
o Ease of insertion - based on a 
post-insertion survey 
Design and Overview 
This is a prospective, observational, single arm study to assess the safety 
and performance of the PowerPICC family of devices.  In the study, 
only patients who require one of the study devices may be considered 
for enrollment.  The choice of device required for individual patients is 
left to the discretion of the clinician. 
Information will be collected on the study participants and devices 
before, during, and after catheter insertion, while the device is 
indwelling, and during device removal to assess both safety and 
performance.  Both short- and long-term use of the PowerPICC devices 
will be assessed as part of the study. 

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Protocol Title 
Prospective Observational Study of the Power PICC Family of Devices 
and Accessories 
Study Devices 
The full range of CE-marked devices marketed in the EU will be 
available for use in this study.  These devices include: 
• PowerPICC 
• PowerPICC SV (Small Vein)  
• PowerPICC FT (Fit for Veins) 
• PowerPICC HF (High Flow) 
• PowerPICC SOLO2,  
• PowerPICC SOLO2 FT  
• PowerPICC SOLO2 HF 
• PowerGroshong PICC Catheters 
• Accessory Guidewires 
• Accessory Stylets 
 
PowerPICC. PowerPICC SOLO2, and PowerGroshong PICC devices 
are intended for both short- (<30 days) and long-term (≥30 days) 
peripheral access to the central venous system for intravenous (IV) 
therapy, blood sampling, infusion, or therapy, and power injection of 
contrast media.  PowerPICC and PowerPICC SOLO2 catheters may also 
be used for central venous pressure measurements. 
 
Guidewires and Stylets:  Guidewires and Stylets must retain integrity 
within the vasculature system and facilitate placement of the catheter.   
 
All devices used in this study will be used in a manner consistent with 
their labelled indications.

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Protocol Title 
Prospective Observational Study of the Power PICC Family of Devices 
and Accessories 
Participants 
Approximately 150 participants for each category of device 
(PowerPICC, PowerPICC SOLO2, and PowerGroshong PICC) will be 
enrolled in the study. 
In order to be eligible to participate in this study, an individual must 
meet all of the following criteria: 
1. Any patient, regardless of age or gender, for which the investigator 
has decided that one of the PowerPICC study devices for either 
short-or long-term venous access should be inserted as standard of 
care  
2. Expected to be available for observation through the duration of 
PICC therapy (including outpatient therapy, if applicable) 
3. Provision of signed and dated informed consent form (Note: Consent 
of guardian or parent may be required for patients under the age of 
18 years; participant assent may be required as well.) 
 
Participants are excluded from the study if any of the following criteria 
apply: 
1. Presence of any device-related infection, bacteremia, or septicemia 
is known or suspected 
2. Body size is insufficient to accommodate the size of implanted 
device 
3. Known or suspected to be allergic to materials contained in the 
device 
4. History of irradiation of prospective insertion site 
5. Previous episode(s) of venous thrombosis or vascular surgical 
procedures at the prospective placement site 
6. Local tissue factors which would prevent proper device stabilization 
and/or access

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Protocol Title 
Prospective Observational Study of the Power PICC Family of Devices 
and Accessories 
Intervention(s)/Procedure(s) After screening against inclusion/exclusion criteria, potential 
participants will be provided with detailed information about the study.  
If the potential participant, or parent/guardian in the case of those under 
18 years of age, provides written informed consent, he/she will be 
enrolled in the study.  Participant baseline and demographic information 
will be documented, including, but not limited to age, gender, primary 
diagnosis, limited medical history, reason for PICC insertion, and 
expected duration of therapy. 
At the time of study device placement, information about the insertion 
procedure will be documented, including, but not limited to: date and 
time of insertion, catheter type, size, and length, insertion location, 
insertion procedure (e.g., components/accessories used), number of 
insertion attempts, stabilization method, dressing type, and total 
procedure time.  Additionally, limited information about the clinician 
performing the procedure will be collected (e.g., years of experience, 
estimated number of PICCs inserted, education level).  Lastly, to assess 
overall ease of insertion, the inserting clinician will complete a brief 
survey describing their experience with the procedure.  
Once the PICC is in place and is accessed for use, data about the use of 
the catheter will be collected including, but not limited to: catheter 
maintenance procedures , types of IV therapy (e.g., antimicrobial, TPN, 
blood products), blood sampling, CVP monitoring, and injection of 
contrast.  While the participant is in the acute care setting, the PICC will 
be assessed daily, as part of the participant’s routine care, until the 
catheter is discontinued or until they are discharged, whichever comes 
first.  If the participant is discharged with the PICC in-situ, assessments 
will be performed at each therapy visit, as part of the participant’s 
routine care.  Assessments will continue as scheduled until the line is 
discontinued or until 180 days (± 14 days) post-insertion, whichever 
comes first.  For the purposes of endpoint calculations, PICCs remaining 
in place after 180 days will be considered to have completed therapy.     
At the time of catheter removal, date and time of removal, reason for 
removal, and site condition will be documented.   
Investigational Sites 
Up to 20 sites in the EU will participate in this study.  No more than 
20% of subjects may be enrolled at any one site. 
Data Monitoring 
Committee 
A Data Monitoring Committee will not be used in this study. 

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Protocol Title 
Prospective Observational Study of the Power PICC Family of Devices 
and Accessories 
Regulatory Status 
This is a post-market study of CE-marked devices currently sold in the 
EU (CE 551344 and CE 551348). 

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1.2 Schedule of Activities 
 
 
Procedure / Study Phase 
Screening/ 
Enrollment 
Insertion 
Use and 
Maintenance 
Removal / Last 
Study Visit* 
(End of Study) 
Notes 
Inclusion and exclusion criteria 
X 
 
 
 
 
Informed Consent 
X 
 
 
 
 
Baseline and demography 
X 
 
 
 
 
Medical history 
X 
 
 
 
 
Catheter insertion 
 
X 
 
 
 
Ease of insertion survey 
 
X 
 
 
 
Use and maintenance assessment 
 
 
X 
 
 
Removal assessment 
 
 
 
X 
 
AE monitoring 
 
X 
X 
X 
 
Device deficiency monitoring 
 
X 
X 
X 
 
*Participants will be followed through device removal or 180 ± 14 days post-insertion, whichever comes first. 
 
 

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2 
INTRODUCTION 
 
The PowerPICC family of devices was introduced to the European market beginning in 
2008 for use in patients requiring short- or long-term peripheral access to the central venous 
system for intravenous (IV) therapy, blood sampling, infusion, or therapy, power injection 
of contrast media, or central venous pressure measurements.   Guidewires and stylets, 
typically packaged with the PICCs, facilitate placement of the catheter.   
 
2.1 Background 
 
Long-term intravascular catheters, also known as vascular access devices (VADs) are  
divided into two major groups based on the entry site: those that are introduced into the 
central venous system via the subclavian, jugular or femoral vein and known as central 
venous catheters (CVCs) and those introduced via the peripheral vessels and known as 
peripherally inserted central catheters (PICCs).  PICCs, used for both long and short-term 
intravascular access, are often chosen over CVCs to avoid or minimize the risks 
associated with placement of subclavian vascular access devices, specifically 
pneumothorax and other pulmonary complications.  PICCs are also used in patients who 
may require therapy over prolonged dwell times to reduce the number of venipunctures 
than typically associated with peripheral intravenous catheters (PIVs) replacements/ 
changes.  Today, PICCs are used for a wide variety of uses including delivery of total 
parenteral nutrition, antimicrobials, blood components, chemotherapy, and other 
infusates, blood sampling, and for central venous pressure monitoring in both critical/ 
acute care and alternate care settings. 
 
In the mid-1990s, catheters made of polyurethane were developed to satisfy clinician 
requests for greater durability and improved flow rates than were available with the 
original silicone catheters. In addition to standard usage, patients who received a PICC 
catheter may also require an injection of contrast media, typically administered with a 
power injector, for enhanced computed tomography (CT).  For these patients, being able 
to administer contrast media through their PICC may be beneficial.  This need led C. R. 
Bard, Inc. to develop and launch the PowerPICC family of devices, indicated for the 
standard uses noted above as well as for administration of contrast media using a power 
injector. 
  
2.2 Rationale 
 
While there is clinical data available on the PowerPICC family of devices, it is limited in 
scope.  This study is being conducted to assess the overall safety and performance of 
these devices in a real-world setting. 
 

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2.3 Risk/Benefit Assessment 
 
Due to the observational nature of the study and the fact that only patients requiring use 
of one of the study devices as part of their standard medical care, there are no anticipated 
risks associated with participation in the study other than those associated with device 
usage.  More detailed information about the known and expected benefits and risks and 
reasonably expected adverse events of PowerPICC devices may be found in their 
respective Instructions for Use (IFUs). 
 
2.3.1 Risk Assessment 
 
Note: Potential risks for the PowerPICC devices are based on complications noted in the 
Instructions for Use and are not unique to this study.   
Potential Risk of Clinical 
Significance 
Summary of 
Data/Rationale for Risk 
Mitigation Strategy 
Study Intervention (s): PowerPICC Device 
• Air embolism 
• Bleeding 
• Brachial plexus injury 
• Cardiac arrhythmia 
• Cardiac tamponade 
• Catheter erosion through skin 
• Catheter embolism 
• Catheter occlusion 
• Catheter related sepsis 
• Endocarditis 
• Exit site infection 
• Exit site necrosis 
• Extravasation 
• Fibrin sheath formation 
• Hematoma 
• Heparin induced thrombocytopenia 
(PowerPICC or SOLO devices only) 
• Hypersensitivity, anaphylactic or 
anaphylactic-like reaction during 
placement, positioning, flushing of 
catheter or cleaning of catheter exit 
site (PowerPICC or SOLO devices) 
• Intolerance reaction to implanted 
device 
• Laceration of vessels or viscus 
• Myocardial erosion 
• Perforation of vessels or viscus 
• Phlebitis 
• Spontaneous catheter tip 
malposition or retraction 
• Thromboembolism 
See device-specific 
Instructions for Use for 
additional information. 
Only patients requiring a 
PowerPICC device as part of 
their standard medical care 
will receive a device.  The 
treating physician will select 
the most appropriate device 
for the patient based on their 
specific needs. 

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Potential Risk of Clinical 
Significance 
Summary of 
Data/Rationale for Risk 
Mitigation Strategy 
• Venous thrombosis 
• Vessel erosion 
• Risks normally associated with local 
or general anesthesia, surgery and 
post-operative recovery 
  
Study Procedures 
No study-specific risks identified  
 
 
Other 
Not applicable 
 
 
 
 
2.3.2 Benefit Assessment 
 
There is no direct benefit for study participation for an individual patient other 
than the placement of one of the study devices which is otherwise required as part 
of their standard medical care. 
 
2.3.3 Overall Benefit: Risk Conclusion 
 
Due to the observational nature of this study, there is no anticipated benefit to an 
individual patient.  Likewise, because a participating patient will receive a study 
device regardless of their participation in the study, there are no anticipated study-
specific risks regardless of the participant’s age or medical condition.   
 
 
3 
OBJECTIVES AND ENDPOINTS 
 
Note: Clinical endpoints are gathered from information collected as part of the participants’ 
routine care. No study specific procedures will be performed. 
Objectives 
Endpoints 
Primary Safety 
 
 To assess the incidence of 
symptomatic venous thrombosis 
(VT) in patients with PowerPICC, 
PowerPICC SOLO2, and 
PowerGroshong PICC devices 
(PICCs) used for both short- and 
long-term venous access. 
 Incidence defined as any new occurrence of 
symptomatic VT defined by thrombus presence by 
ultrasonography or other imaging 

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Primary Performance 
 
 To assess the rate of therapy 
completion in PICCs used for 
both short- and long-term therapy. 
 
 Percent of PICCs that remain in place through the 
required therapy time period (completion of therapy) 
(success/failure) 
Secondary Safety 
 
 To assess the incidence of select 
complications during catheter 
insertion and while the catheter is 
in-situ in patients with PICCs 
used for both short- and long-term 
venous access.   
 Incidence defined as any new occurrence of: 
o Phlebitis – inflammation of the cannulated vessel 
identified by redness, swelling, warmth, tenderness, 
and/or cord formation 
o Extravasation – accidental infiltration of a vesicant 
or chemotherapeutic drug into the tissue around the 
catheter 
o Local infection - presence of pus at the exit site 
and/or culture confirmed site infection 
o Catheter-related bloodstream infection - positive 
blood culture(s) with a microorganism not related to 
another source (e.g., UTI) OR positive blood 
culture(s) with microorganism matching catheter tip 
culture OR blood cultures from peripheral venous 
puncture and PICC positive with the same 
microorganism 
o Accidental dislodgement – catheter accidentally 
dislodged the extent to which it requires replacement 
o Vessel laceration – a tear in the tissue of the vessel 
o Vessel perforation – a hole formed in the vessel
Secondary Performance 
 
 To assess the incidence of select 
performance measures in PICCs 
used for both short- and long-term 
therapy. 
 Percent of patent catheters (number of functional 
catheters through therapy/total number of catheters) 
 Percent of placement success in single insertion 
attempt (placement success defined as single insertion 
attempt, proper tip location, and patent catheter) 
(successful placement / total insertions)  
 Usability  
o Ease of insertion - composite score of 
guidewire/stylet performance based on post-insertion 
survey 
 
 
 

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4 
STUDY DESIGN 
 
4.1 Overall Design 
 
This is a multi-center, single-arm, prospective, observational, post-market study of the 
PowerPICC family of devices used for both short- and long-term therapy.  Only 
participants requiring the use of a study device as part of their standard medical care may 
be enrolled in the study.  Study enrollment is expected to take 6 – 12 months. 
 
4.2 Scientific Rationale for Study Design 
 
This study is designed to assess the real-world safety and efficacy of the PowerPICC 
family of devices used in an on-market fashion.  The observational design will ensure 
that study activities have no direct impact on the endpoints being assessed and that they 
represent outcomes typically associated with standard medical use of the study devices. 
 
4.2.1 Participant Input into Design 
 
Participant input was not sought while designing the study; however, similar 
published studies were reviewed.  
 
4.3 End of Study Definition 
 
A participant is considered to have completed the study if he/she has completed all 
phases of the study including study device removal or achievement of 180 ± 14-day dwell 
time (last study assessment).  Data collection will cease for the study participant at this 
point regardless of whether or not the device remains in place. 
 
The end of the study is defined as the date of the last study assessment of the last 
participant in the study. 
 
 
5 
STUDY POPULATION 
 
Participants will be recruited from the patient population treated at the investigational sites.  
Sites may choose to limit recruitment to specific areas of the hospital and/or to patients 
treated by specific healthcare providers. 
 
5.1 Inclusion Criteria 
 
In order to be eligible to participate in this study, an individual must meet all of the 
following criteria: 
 
 

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1. Any patient, regardless of age or gender, for which the investigator has decided 
that one of the PowerPICC study devices for either short-or long-term venous 
access should be inserted as standard of care  
2. Expected to be available for observation through the duration of PICC therapy 
(including outpatient therapy, if applicable) 
3. Provision of signed and dated informed consent form (Note: Consent of guardian 
or parent may be required for patients under the age of 18 years; participant assent 
may be required as well.) 
 
5.2 Exclusion Criteria 
 
Participants are excluded from the study if any of the following criteria apply: 
 
1. Presence of any device-related infection, bacteremia, or septicemia is known or 
suspected 
2. Body size is insufficient to accommodate the size of implanted device 
3. Known or suspected to be allergic to materials contained in the device 
4. History of irradiation of prospective insertion site 
5. Previous episode(s) of venous thrombosis or vascular surgical procedures at the 
prospective placement site 
6. Local tissue factors which would prevent proper device stabilization and/or access 
 
5.3 Lifestyle Considerations 
 
Because of the real-world design of this study, there are no study-specific restrictions 
other than those typically associated with use of a study device (e.g., keeping the 
insertion area clean and dry). 
 
5.4 Screen Failures 
 
Screen failures are not anticipated due to the observational nature of the study.   
 
 
6 
STUDY INTERVENTION 
 
6.1 Investigational/Test Device 
 
Peripherally inserted central catheters (PICCs) are a group of single-, double-, or triple-
lumen central venous access catheters composed of silicone elastomer or polyurethane, 
typically 40 cm to 70 cm in usable length and 2F to 6F in diameter, whose tips terminate 
centrally in the Superior Vena Cava (SVC).  Because these devices are placed centrally, 
they can be used to deliver a wide variety of parenteral therapies that can potentially 
cause chemical phlebitis or other vessel damage or irritation when infused through 
Peripheral intravenous catheters (PIVs) or midline catheters whose tips are not located in 
the SVC.  PICCs can be either open- or closed-ended.  Open-ended PICCs typically 

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require a clamp attached to their extension tubing to prevent blood from back up into the 
catheter or tubing.  A closed-ended PICC has a valve at the distal end that prevents blood 
reflux into the catheter lumen. The valve remains closed unless exposed to pressure 
changes such as those exerted at the catheter hub to withdraw or infuse fluids through the 
catheter lumen. 
 
The PowerPICC family of catheters are indicated for short- or long-term peripheral 
access to the central venous system for intravenous therapy, power injection of contrast 
media, and allows for central venous pressure monitoring.  For blood sampling, infusion, 
or therapy a 4 French or larger catheter should be used. The maximum recommended 
infusion rate is 5mL/sec for power injection of contrast media. For central venous 
pressure monitoring, a catheter lumen of 20 gauge or larger be used.  Table 6.1 provides 
an overview of the device variants available for use. 
 
 
Table 6.1 Device Variants 
Type 
Design 
Material 
Lumens Size(s) Length(s) (cm) 
PowerGroshong PICC 
Closed-ended 
Silicone 
Single 
5F 
40/45/55 
PowerPICC 
Open-ended 
Polyurethane
Single 
4F, 5F 
55 
Double 
5F, 6F 
55 
Triple 
6F 
55 
PowerPICC FT 
Open-ended 
Polyurethane
Double 
5F 
55 
PowerPICC HF 
Open ended 
Polyurethane
Double 
5F 
55 
PowerPICC SV 
Open-ended 
Polyurethane
Single 
3F 
45 
Double 
4F 
45 
PowerPICC SOLO 
Open-ended; 
pressure-activated 
proximal hub valve
Polyurethane
Single 
4F, 5F 
55 
Double 
5F, 6F 
55 
Triple 
6F 
55 
PowerPICC SOLO FT 
Open-ended; 
pressure-activated 
proximal hub valve
Polyurethane
Double 
5F 
55 
PowerPICC SOLO HF 
Open-ended; 
pressure-activated 
proximal hub valve
Polyurethane
Triple 
5F 
55 
See device specific IFUs for more detailed information (References 2 – 16). 
 

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6.2 Control Device/Standard of Care 
 
This is a single-arm study; no control device will be used. 
 
6.3 Ancillary Devices/Products 
 
The PowerPICC family of devices are available in multiple tray (kit) configurations.  
These trays typically contain ancillary materials used during catheter insertion 
procedures.  These trays may contain one or more of the following components: 
 Microintroducer 
 Scalpel 
 Introducer needles 
 End cap 
 Syringes 
 StatLock Stabilization Device 
 Measuring tape 
 Filter straw 
 Wound closures 
 Transparent dressing 
 Drape, fenestrated 
 Drape, full body, fenestrated 
 Bouffant cap 
 Surgical gown 
 Towel, absorbent 
 Poly underdrape 
 Tourniquet 
 Face mask 
 Surgical tape 
 Scissors 
 Surgical gloves, sterile 
 Antiseptic skin preparation 
 Lidocaine 
 Saline 
 Gauze pads 
 
6.4 Device Labeling 
 
This study will utilize shelf-stock devices.  As such, no special labelling is required. 
 
6.5 Treatment Allocation and Measures to Minimize Bias 
 
In this single-arm study, the choice of the specific device type, size, number of lumens, 
and length required for an individual patient is left to the discretion of the clinician. 
 

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7 
STUDY PROCEDURES AND ASSESSMENTS 
 
 Study activities and their timing are summarized in the Schedule of Activities (SoA), 
Section 1.2.  
 Protocol waivers or exemptions are not allowed. 
 Adherence to the study design requirements, including those specified in the SoA, is 
essential and required for study conduct. 
 All inclusion/exclusion criteria must be reviewed to confirm that potential 
participants meet all eligibility criteria.  
 
7.1 Screening and Enrollment 
 
After screening against inclusion/exclusion criteria, potential participants will be 
provided with detailed information about the study.  If the potential participant, or 
parent/guardian in the case of those under 18 years of age, provides written informed 
consent, he/she will be enrolled in the study. 
 
7.2 Medical History / Baseline Assessments 
 
After enrollment, participant baseline and demographic information will be documented, 
including, but not limited to:  
 Age 
 Gender 
 Primary diagnosis 
 Limited medical history (e.g., vascular disease, coagulopathy, anticoagulant 
therapy) 
 Reason for PICC insertion 
 Expected duration of PICC use (i.e., short- vs. long-term) 
 
7.3 Index Procedure 
 
Choice of the specific PowerPICC type, size, number of lumens, and length required for 
an individual patient is left to the discretion of the clinician.  The device and insertion site 
will be prepared according to the device specific IFU.  The device will be inserted, and 
catheter tip location will be confirmed according to standard medical practice and 
according to the device specific IFU.    Once proper placement is confirmed, the 
procedure will be completed, the catheter aspirated and flushed, and secured/stabilized 
according to the device specific IFU.  The insertion site will be dressed according to the 
IFU and hospital-specific protocols.   
 
7.3.1 Procedure Data  
 
After the PICC is in place, information about the insertion procedure will be 
documented, including, but not limited to:  

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 Date and time of insertion 
 Catheter type, size, and length 
 Insertion location 
 Insertion procedure (e.g., components/accessories used including 
guidewires/stylets) 
 Number of insertion attempts 
 Stabilization method/securement method 
 Dressing type 
 Total procedure time 
 Adverse events/complications (including but not limited to study endpoints 
such as laceration/perforation of vessel) 
 Device deficiencies/failures  
 Inserting clinician experience (e.g. years of experience, estimated number of 
PICCs inserted, education level) 
 
7.3.2 Ease of Insertion Procedure Survey 
 
After the catheter is inserted and procedure data is recorded, the inserting 
clinician will complete a short survey to assess the performance of the 
guidewire/stylet. 
 
7.4 Use and Maintenance Procedures 
 
The PowerPICC device will be used for therapy as medically required, according to the 
IFU and hospital protocol.  The device will be maintained (i.e., flushing, fluid locking, 
cleansing) and the site maintained (i.e., cleansing, dressing) according to the device 
specific IFU, standard medical practice, and hospital protocols. 
 
When the participant is treated in an acute-care setting, the catheter/site will be assessed 
daily until the device is removed or until they are discharged with the device in place 
(then treated as an outpatient).  When the participant is treated in an outpatient setting, 
the catheter/site will be assessed at each therapy visit until the device is removed, or until 
180 days post-insertion (±14 days), whichever comes first.  For the purposes of endpoint 
calculations, PICCs remaining in place after 180 days will be considered to have 
completed therapy. 
 
7.4.1 Use and Maintenance Data 
 
Device assessments will be conducted as part of the participant’s routine medical 
care.  Information from these assessments about the use and maintenance of the 
PICC will be documented, including, but not limited to: 
 Catheter patency 
 Performance of catheter/site maintenance procedures  
 Type of use (i.e., IV therapy (e.g., antimicrobial, TPN, blood products), 
blood sampling, CVP monitoring, injection of contrast media) 

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 Adverse events/complications (including but not limited to study 
endpoints such as extravasation, VT, phlebitis, infection, etc.) 
 Device deficiencies/failures (including but not limited to accidental 
dislodgement and occlusion) 
 
7.5 Device Removal Procedure 
 
The study device will be discontinued/removed when it is deemed medically appropriate 
by the participant’s treating clinician (e.g., no longer needed, no longer functioning).  
Removal of the device will be performed according to the device specific IFU, standard 
medical practice, and hospital protocols. 
 
7.5.1 Device Removal Data 
 
At the time of device removal, the following data will be collected: 
 Date and time of device removal 
 Reason for removal (e.g., completion of therapy, device failure) 
 Site condition 
 
Note: Should the catheter remain in place through 180 days without removal, day 
180, or the last study visit occurring 180 ± 14 days, will be documented as the 
final catheter day for the purposes of dwell-time calculations.   
 
 
8 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
 
8.1 Discontinuation/Withdrawal 
 
 A participant may withdraw from the study at any time at his/her own request or may be 
withdrawn at any time at the discretion of the investigator or sponsor for safety, 
behavioral, compliance, or administrative reasons. This is expected to be uncommon. 
 At the time of discontinuing from the study, no further data will be collected for the 
participant. 
 If the participant withdraws consent for disclosure of future information, the sponsor may 
retain and continue to use any data collected before such a withdrawal of consent. 
 Participants who withdraw or discontinue the study early (e.g., prior to PICC insertion) 
may be replaced. 
 
8.2 Lost to Follow-Up 
 
A participant will be considered lost to follow-up if he or she repeatedly fails to return 
for/complete therapy visits and is unable to be contacted by the study site. 
 
 
 

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9 
ADVERSE EVENTS AND DEVICE DEFICIENCIES 
 
9.1 Definitions of Events 
 
9.1.1 Adverse Events (AEs) 
 
An AE is defined as any 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.  In this study, AE collection will be limited to those occurring in 
the arm in which the device is inserted or upper torso, as well as any other 
undesirable clinical event judged to be related or likely related to the PowerPICC 
device or the suture or stabilization method used for securement of the device,  
regardless of anatomical region, that in the opinion of the investigator warrants 
reporting. 
 
Pre-existing conditions should be considered as part of the participant’s medical 
history and should not be reported as an AE unless there is a substantial increase 
in severity or frequency of the condition, which has not been attributed to natural 
history.  Exacerbation of an existing condition should be reported as an AE if the 
event meets the protocol definition of an AE.  
 
The clinical course of the event will be followed according to accepted standards 
of medical practice until the event resolves, stabilizes, or in the opinion of the 
Investigator, is no longer considered clinically significant.  The Investigator must 
supply the Sponsor with information concerning the follow up and/or resolution 
of the AE. 
 
9.1.2 Serious Adverse Events (SAEs) 
 
A serious adverse event is defined by ISO 14155 as an adverse event that:  
a. led to death, 
b. led to serious deterioration in the health of the subject, that either resulted 
in 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, 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 foetal distress, foetal death or a congenital abnormality or birth 
defect 
 
NOTE: Planned hospitalization for a pre-existing condition, without serious 
deterioration in health, is not considered a serious adverse event. Likewise, 
conditions in the medical history leading to elective hospital stays (e.g. 
chemotherapy treatment) should not be considered as serious adverse events.   

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9.1.3 Adverse Device Effect (ADE) / Serious Adverse Device Effect (SADE) 
 
An adverse device effect is defined as any adverse event that is considered to be 
related to the use of an investigational medical device. This definition includes 
any event resulting from insufficiencies or inadequacies in the instructions for 
use, deployment, implantation, or operation or any malfunction of the 
investigational device (study device) and includes any event that is a result of a 
user error. 
 
A serious adverse device effect (SADE) is defined as an ADE that has resulted in 
any of the consequences characteristic of an SAE. 
 
9.1.4 Unanticipated (Serious) Adverse Device Effect (UADE/USADE) 
 
An unanticipated (serious) adverse device effect (UADE/USADE) is any (serious) 
adverse device effect on health or safety or any life-threatening problem or death 
caused by, or associated with, a study device, which by its nature, incidence, 
severity, or outcome has not been identified in the current instructions for use 
and/or current version of the risk analysis report, or any other unanticipated 
serious problem associated with a device that relates to the rights, safety or 
welfare of participants (see Section 2.3.1). 
 
UADEs/USADEs will be reported to FDA as required by 21 CFR Part 812 and to 
the appropriate governing body per ISO 14155:2011(E). 
 
9.2 Severity of Adverse Events 
 
Each AE shall be assessed for its severity, or the intensity of an event, experienced by the 
participant according to the criteria below. 
 
Severity Rating 
Description
Mild 
Event, signs, or symptoms that do not interfere with the participant’s 
daily activity, are usually considered self-limiting, can be treated 
with non-prescription type medications, and do not require medical 
intervention
Moderate 
Event may interfere or cause low level inconvenience with the 
participant’s daily activity. Requires medical intervention and/or 
treatment; however, unlikely to require hospitalization or be 
considered potentially life-threatening in nature 
Severe 
Event may cause significant discomfort to the participant and/or 
interferes with the participant’s daily activity. Requires medical 
intervention and/or treatment to preclude a permanent impairment; 
may be life threatening and/or require hospitalization 
 
 

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9.3 Relationship of Adverse Event to Device(s)/Procedure 
 
Each AE will be assessed for its relationship to the study device or procedure according 
to the following guidelines. 
 
A.  Assess each AE for its relationship to the device or procedure. 
 
 Device Related: This category should be restricted to AEs directly attributable to 
the study device used. 
 
 Procedure:  A procedure includes any activity performed with the study device  
 
B.  The following categories shall be used for assigning the certainty of the relatedness. 
 
Relatedness 
Description
Not Related 
Event is independent of study intervention and/or evidence 
exists that the event is related to another etiology. There must 
be an alternative etiology documented by the clinician.
Unlikely Related 
Event in which the temporal relationship to study intervention 
makes a causal relationship improbable (e.g., the event did not 
occur within a reasonable time of the study device use) and in 
which underlying disease provides plausible explanations (e.g., 
the participant’s clinical condition other concomitant 
treatments).
Likely Related 
Event in which there is evidence to suggest a causal 
relationship and the influence of other factors is less likely. 
The event occurs within a reasonable time after use of the 
study device and is less likely to be attributed to concurrent 
disease.
Related 
Event in which there is clear evidence to suggest a causal 
relationship and other possible contributing factors can be 
ruled out. The event occurs in a plausible time relationship to 
use of the study device and cannot be explained by concurrent 
disease.
 
 
9.4 Reporting of Events 
 
For all adverse collected events, all sections of the appropriate Case Report Form (CRF) 
must be completed. 
 
 All SAEs, SADEs, and/or UADEs/USADEs must be reported to the Sponsor via 
the electronic CRF without unjustified delay and within three (3) working days of 
the site/investigator becoming aware of the event.   
 

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 De-identified copies of all requested relevant documentation should be submitted 
to the Sponsor within 72 hours of knowledge, as appropriate.  
 
It is the responsibility of the Investigator or their designee to report adverse events to 
individual Institutional Review Boards (IRBs)/Ethics Committees (ECs).  The Sponsor or 
their designee is responsible for reporting AEs to regulatory authorities according to the 
local regulations in each participating country. 
 
9.5 Safety Committees 
 
There will be no Safety Committee used in this study.  
 
9.6 Device Deficiencies 
 
The Investigator will record, without unjustified delay, a device deficiency if a device 
used failed to meet its performance specifications whether due to mechanical failure, 
malfunction, or defect.  Device deficiencies also include use errors and inadequate 
labeling.  This applies to: devices used to treat the participant, or devices in which the 
package was opened, but the device was not used for treatment, or devices with which 
treatment was attempted, but the device did not remain through the entire study period. 
 
All mechanical failures, malfunctions, missing components, and defects of the study 
devices will be recorded on the appropriate Case Report Form and will be promptly 
reported to the Sponsor. The device(s) should be returned to the Sponsor if requested. 
 
If the device deficiency was associated with an AE, the reporting provisions for AEs, 
ADEs, SAEs, SADEs and UADEs/USADEs apply. 
 
Reported deficiencies will be investigated and reported as required by appropriate 
national laws and regulations.  The site may be contacted to provide additional 
information to allow the Sponsor to conduct a thorough investigation. 
 
It is the responsibility of the Investigator, or their designee, to notify the IRB/EC of such 
device deficiencies in accordance with the IRB/EC and/or local regulations. 
 
10 STATISTICAL METHODS 
 
The statistical analysis plan will be finalized prior to the interim analysis and will include a 
more technical and detailed description of the statistical analyses described in the following 
sections. This section includes a summary of the planned statistical analyses of the most 
important endpoints including primary and key secondary endpoints. 
 
10.1 Overview of Study Design 
 
This is a multi-center, single-arm, prospective, observational study to assess the overall 
safety and performance of the PowerPICC family of devices.   

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10.2 Sample Size Considerations 
 
The primary safety endpoint of the study is the incidence of venous thrombosis. The 
expected venous thrombosis rate is about 10% based on literature review.1 The statistical 
rationale of the sample size is based on precision of the point estimates of the primary 
endpoint, as well as the ability to observe rare adverse events or complications.  
Assuming the primary endpoint of VT incidence is 10% for a specific type of device, 
with a sample size of 150, the precision of the point estimate is 4.8% (i.e. the 95% 
confidence interval is the point estimate plus/minus 4.8%). 
 
Additionally, with a sample size of 150, the probability of observing at least one rare 
AE/complication with a 1% rate is 78% and the probability of observing at least one rare 
AE/complication with a 2% rate is 95%. 
 
A sample size of 150 is proposed for each type of device (PowerPICC, PowerPICC 
SOLO, and PowerGroshong PICC) for a total of 450 participants in the study. 
 
10.3 Analysis Population 
 
The following populations are defined: 
Population 
Description 
Enrolled  
All participants who sign the ICF
Evaluable 
All participants who undergo successful placement of a study 
device and receive at least one treatment through it 
 
 
10.4 Primary Endpoint(s) 
 
10.4.1 Safety 
 
Venous thrombosis will be defined as the presence of symptomatic thrombus 
confirmed by ultrasonography or other imaging. The incidence rate of 
symptomatic VT will be calculated as the number of participants with 
symptomatic VT incidence divided by the total number of participants; 95% 
confidence interval will be calculated.  
 
10.4.2 Performance 
 
The percentage of PICCs that remain in place through the completion of therapy 
(success) will be calculated by dividing successful cases by the total number of 
cases (total number of participants completing therapy with single PICC / total 
number of participants); 95% confidence interval will be calculated.  
 
 

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10.5 Secondary Endpoint(s) 
 
Secondary endpoints will be analyzed in the following manner: 
 For each complication listed as a secondary endpoint, the incidence of each 
complication will be calculated by dividing the number of participants experiencing 
the event by the total number of participants; 95% confidence intervals will be 
calculated where appropriate.   
 The percent of patent catheters will be calculated by dividing the number of catheters 
remaining functional through completion of therapy by the total number of catheters; 
95% confidence intervals will be calculated where appropriate. 
 The percent of placement success in a single insertion attempt will be calculated by 
dividing the number of catheters that are placed in a single attempt with proper tip 
location, and catheter patency by the total number of insertions; 95% confidence 
intervals will be calculated where appropriate. 
 The usability of guidewires/stylets will be analyzed based on a composite score of 
performance questions administered in a post-insertion survey where 1 represents the 
best possible score and 5 represents the worst possible score.  Scores for individual 
survey questions will be analyzed separately as well. 
 
Summary statistics for categorical variables will include frequency counts and 
proportions and for continuous variables mean, standard deviation, minimum, median 
and maximum. Further details will be included in the final Statistical Analysis Plan 
(SAP). 
 
10.6 Interim Analysis 
 
An interim analysis, to assess study progress, will be targeted when 50% of the subjects 
have completed the study, or sooner, based on reporting requirements.  Details of the 
analysis will be defined in the statistical analysis plan. 
 
11 DATA COLLECTION AND RECORD MAINTENANCE 
 
11.1 Case Report Forms 
 
The Investigator is responsible for ensuring the completeness and accuracy of all study 
documentation. 
 
All required clinical data will be collected/documented in sponsor-provided electronic 
Case Report Forms (CRFs).  Applicable national and local regulations are followed on 
the handling of electronic data.  Modification of the CRFs will only be made if deemed 
necessary by the Sponsor and/or the appropriate regulatory body. 
 
Site numbers and participant numbers will be used to track participant information 
throughout the study.  Participant personal information will be pseudonymized/de-
identified. 
 

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11.2 Source Documentation 
 
Original or certified copies of all relevant clinical findings, observations, and other 
activities throughout the clinical investigation must be recorded and maintained in the 
medical and/or study file of each enrolled participant.  Where there is no prior written or 
electronic record of data, such as clinical surveys, these data may be recorded directly on 
the CRF(s) and the CRF is then considered to be the source.  In this study, the following 
CRFs will serve as original source documents: Insertion Procedure Details and Ease of 
Insertion Survey. 
 
11.3 Data Management 
 
Data management is the responsibility of the Sponsor or their designee.  Data from 
completed CRFs will be managed in a secured, controlled database.   A Data 
Management Plan (DMP) will be developed that outlines the procedures used for data 
review, database cleaning and issuing/resolving data queries. Procedures for validations 
and data storage will also be contained within the DMP.   
 
11.4 Record Retention 
 
The Investigator shall retain all study records for a minimum of two (2) years after the 
date on which the study is terminated/completed.  Study records may be stored longer if 
required by national law or other local rules.  The data for some of these records may be 
available in computerized form but the final responsibility for maintaining study records 
remains with the Investigator. 
 
The Investigator may withdraw from the responsibility to maintain records for the period 
required by transferring custody of the records to any other person who will accept 
responsibility for retaining them. Notice of a transfer shall be given to the Sponsor not 
later than ten (10) working days after the transfer occurs. 
 
12 QUALITY CONTROL AND ASSURANCE 
 
12.1 Control of Study Products 
 
In this observational, real-world study, shelf-stock of study devices will be used.  
Clinicians may choose and use any study device that is available for use in their 
institution and that is medically appropriate for use in study participant.  No special 
controls are required in this study.  
 
12.2 Monitoring 
 
The Sponsor or their designee will designate trained and qualified personnel to monitor 
the progress of this clinical study in accordance with established standard operating 
procedures and the study-specific Monitoring Plan.   
 

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Prior to study start, a study initiation visit (SIV) will be conducted to review with the 
Investigator(s) and staff the provisions and proper conduct of this study. This visit will 
include a detailed review of this protocol, verification that all necessary documents are on 
file at the investigational site and confirmation of IRB/EC approvals.   
 
During the study, routine monitoring visits (RMVs) will be conducted to assure the site 
continues to adhere to the protocol, the investigator agreement, and regulations regarding 
conduct of clinical studies.  The Sponsor-Clinical Research Associate (CRA) will 
confirm that the ICF to be used is the version approved by the IRB/EC, confirm the 
applicable national privacy laws have been followed, verify that all necessary documents 
are on file at the investigational site and confirm that there are provisions to continue and 
maintain all documents and records throughout the study as required by applicable 
regulations. These monitoring visits will assess continued protocol compliance, adequate 
participant enrollment, accurate data reporting, monitoring of participant safety through 
identification and/or review of any device-related AEs, UADEs, or SAEs, device 
accountability, continued maintenance and calibration of study-specific equipment (if 
applicable), and continued IRB/EC acceptance of the study. 
 
At the completion of the study, the Sponsor-CRA will conduct a final close-out visit or 
COV. The purpose of this visit may include but is not limited to collecting all outstanding 
study data documents, confirming that the Investigator’s files are accurate and complete, 
reviewing the record retention requirements with the Investigator and ensuring that all 
applicable requirements for closure of the study are met.  
 
12.3 Audits and Inspections 
 
If the study is selected for audit by the Sponsor or if there is an inspection by the 
appropriate regulatory authorities, the Investigator and his team will make themselves 
available during the visit.  The Investigator must agree to the inspection of all study 
related records and give the auditor/inspector direct access to source documents for 
verification of data on CRFs.  The participant’s anonymity must be ensured, and data 
checked during the audit must remain confidential. 
 
As soon as the Investigator is aware of an upcoming inspection/audit by the regulatory 
authorities, he/she will promptly inform the Sponsor.  As agreed with the Investigator, 
Sponsor personnel may be present at the site during the inspection. 
 
12.4 Protocol Deviations 
 
A protocol deviation is defined as an event where the Investigator or site personnel did 
not conduct the study according to the protocol. 
 
Except when necessary to protect the life or physical well-being of a participant, protocol 
deviations are not permitted.  The Sponsor and the investigational site’s IRB/EC must be 
notified immediately if an emergency situation arises in which the safety of a participant 
may require immediate intervention different than that defined in the protocol.  This must 

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be followed by written confirmation that describes the emergency action and outcomes, 
within five (5) working days from the date of the emergency action in accordance with 
the governing IRB/EC’s requirement.   
 
It is the Investigator’s responsibility to ensure that there are no deviations from the 
Protocol.  Except in an emergency, a protocol deviation requires Sponsor approval.   
Any and all deviations must be recorded on the appropriate CRF regardless of whether 
medically justifiable or Sponsor approved.  Upon evaluation by the Sponsor, actions may 
be required to prevent additional deviations, such as retraining of the site, implementation 
of additional site procedures, and more frequent monitoring.  If these steps fail, more 
serious measures, up to and including termination of enrollment at the site may be 
considered. 
 
13 ADMINISTRATIVE REQUIREMENTS 
 
13.1 Investigator and Site Selection 
 
The Investigator must be of good standing as an Investigator and knowledgeable in 
relevant areas of clinical research to ensure adherence to the requirements of this 
protocol, including the protection of human participants.  Other site personnel must have 
appropriate research experience and infrastructure to ensure adherence to this protocol 
and enrollment of sufficient numbers of evaluable participants. The curriculum vitae 
(CV) of the Investigator(s), Sub-Investigator(s) and Study Coordinator(s) will be 
maintained in the Sponsor’s files as documentation of qualification by training and 
experience. 
 
The Principal Investigator will sign the Investigator Agreement pages of this protocol, 
agreeing to comply with all applicable regulations and the requirements of this study as 
per the clinical study agreement.   
 
Any site that is deactivated prior to initial enrollment, either by the Sponsor or by the 
individual site itself, may be replaced. 
 
13.2 Training 
 
Each Investigator and appropriate site personnel will be trained on this protocol and study 
requirements during the Site Initiation Visit.  All training will be documented and filed at 
the investigational site and with the Sponsor. 
 
13.3 Required Documents 
 
An Investigator may not screen or enroll participants until authorized to do so by the 
Sponsor. At a minimum, the following documentation should be received by the Sponsor 
prior to the commencement of study activities: 
 Fully executed Non-disclosure Agreement (NDA) between PI/site and Sponsor; 

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 CVs, signed and dated within 2 years of study start for the PI and Sub-
Investigator(s)] 
 CVs for Study Coordinator(s); 
 Signed CSA by PI/site (or designee); 
 Signed Investigator Agreement Page by PI and Sub-Investigator(s); 
 Signed Financial Disclosure Statement by PI and Sub-Investigator(s); 
 Completed and Signed Training Log by PI and Sub-Investigator(s); 
 Study Personnel Identification list; 
 Written approval from the IRB/EC of both the protocol and ICF, and any other 
 applicable protocol specific material; and 
 IRB/EC Membership List, Assurance of Compliance Form, or equivalent. 
 
13.4 Publication Policy 
 
The sponsor believes that results of applicable clinical studies should be published in 
peer-reviewed literature in a timely, accurate, complete and balanced manner, regardless 
of study outcomes, whenever possible.  As such, at the conclusion of this study, an article 
may be prepared for publication in a reputable scientific journal.  Formal presentation(s) 
or publication(s) of data collected from this study will be considered as a joint publication 
by the investigator(s) and the appropriate personnel of the Sponsor. Authorship will be 
based on generally accepted criteria of the ICMJE (International Committee of Medical 
Journal Editors) and determined by mutual agreement. 
 
The publication of the principal results from any single-center experience within the 
study is not allowed until the preparation and publication of the multicenter results. 
Exceptions to this rule require the prior approval of the Sponsor. The analysis of other 
pre-specified and non-pre-specified endpoints will be performed by the Sponsor or its 
designee. Such analyses, as well as other proposed investigations or manuscripts will 
require the approval of the Sponsor. 
 
13.5 Study Registration 
 
This is a not an Applicable Clinical Trial and does not meet the FDA Amendments Act of 
2007 (FDAAA) criteria for clinical study registration; however, to ensure transparency, 
the study will be registered on www.clinicaltrials.gov.  The study will also be registered 
on applicable local registries. 
 
13.6 Termination of Study 
 
The Sponsor reserves the right to suspend enrollment or terminate the study at any time 
for any reason.  The Sponsor may suspend enrollment or terminate the study at a 
specific investigational site for reasons including, but not limited to, inadequate data 
collection, low participant enrollment rate, achievement of the total enrollment, 
conditions imposed by the reviewing IRB/EC and/or non-compliance with this protocol 
or other clinical research requirements. Written notice will be submitted to the 
Investigator in advance of such termination.  

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In the event of study suspension or termination, the Sponsor will send a report outlining 
the circumstances to the IRB/EC, and all Investigators and Regulatory Authorities as 
required by regulation.  
 
14 ETHICAL AND REGULATORY CONSIDERATIONS 
 
14.1 IRB/EC Approval 
 
Investigators or designees must submit the study protocol, Informed Consent Form (and 
pediatric assent form if applicable), and all other locally required documentation to an 
appropriate IRB/EC and obtain study-specific written approval (favorable opinion) before 
being allowed to participate in the study. Before commencement of the study, the 
Investigator or designee must provide the Sponsor with written documentation of such 
approval.  The IRB/EC must give written renewal of the original approval at least annually 
to continue the study. A copy of the written renewal must be provided to the Sponsor. 
 
The IRB/EC will be notified of any amendments to the protocol, as well as possible 
associated information and consent form changes, where applicable, and written approval 
(favorable opinion) will be obtained prior to implementation, as applicable. 
 
The Investigator or designee is responsible for fulfilling any conditions of approval 
imposed by the IRB/EC, such as regular safety reporting, study timing, etc. The 
Investigator or designee will provide the Sponsor with copies of such reports. 
 
14.2 Informed Consent and Confidentiality 
 
Prior to any study activity, the Investigator (or designee) must explain to each participant 
in layman’s terms, the nature of the study, its purpose, expected duration, and the risks 
and benefits of study participation. Also, participant will be informed of uses and 
disclosures of their medical information for research purposes, and their rights to access 
information about them. All applicable national privacy laws (e.g., GDPR requirements 
in the E.U.) will be followed in this study. The participants must be informed of their 
right to withdraw from the study at any time and for any reason without sanction, penalty, 
or loss of benefits to which they are otherwise entitled, and that withdrawal from the 
study will not jeopardize their future medical care. Participants will be informed of their 
right to new information and/or findings relating to the clinical study, and the process by 
which this information is made available. After this explanation, given sufficient time to 
decide whether to participate before entering the study, the participant must voluntarily 
provide consent in accordance with ISO 14155:2011(E). The participant will receive a 
copy of his/her signed ICF. 
 
14.2.1 Confidentiality 
 
Participant confidentiality must be strictly held in trust by the Investigator, study 
staff, and the Sponsor.  Participant confidentiality and anonymity will be 

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maintained by removal of identifiers from any data, documentation, or clinical 
samples submitted to the Sponsor. 
 
Any data collected meeting the definition of protected/confidential health 
information or personal identifying information will be collected and maintained 
using the designated authorizations and following privacy procedures as specified 
in the applicable regulatory authority regulations including the European Union 
General Data Protection Regulation (GDPR).   
 
The Sponsor-CRA, authorized representatives of the sponsor, and/or applicable 
regulatory authorities may inspect all documents and records required to be 
maintained by the Investigator.  The Investigator/Site will permit access to such 
records.  
 
14.3 Regulatory Status 
 
The study devices are CE marked and will be studied in a post-market fashion in Europe. 
 
14.4 Statement of Compliance 
 
This clinical investigation will be conducted in compliance with the protocol and 
following regulatory requirements: 
 ISO14155:2011 (Good Clinical Practice); 
 EU MDR (Council Regulation 2017/745 of 5 April 2017); 
 Ethical principles of the Declaration of Helsinki, in its current revision; and 
 Applicable sections of the national laws and regulations. 
 
The clinical investigation will not commence at a clinical site until approval (favorable 
opinion) from the respective IRB/EC has been received. All additional requirements 
imposed by the IRB/EC(s) will be followed. Involvement of the national competent 
authorities (e.g. by notification, seeking authorization) will be accomplished as required 
by national laws and regulations. 
 
 

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15 REFERENCES 
 
1. Chopra, V. Peripherally inserted central catheter (PICC)-related venous thrombosis. 
UpToDate, 2019. www.uptodate.com Referenced 05 August 2019. 
2. PowerPICC, Gravity Flow and Power Injection Insert (BAW0741905) 
3. PowerPICC, Microintroducer, Interventional Radiology IFU (BAW0740757) 
4. PowerPICC, Microintroducer, Nursing IFU (BAW0740756) 
5. PowerPICC SV, Microintroducer, Interventional Radiology IFU (BAW0743785) 
6. PowerPICC SV, Microintroducer, Nursing IFU (BAW0743784) 
7. PowerPICC SOLO, Gravity Flow and Power Injection Insert (BAW0741906) 
8. PowerPICC SOLO, Microintroducer, Interventional Radiology IFU (BAW0740759) 
9. PowerPICC SOLO, Microintroducer, Nursing IFU (BAW0740758) 
10. PowerGroshong, Gravity Flow and Power Injection Insert (BAW0743526) 
11. PowerGroshong, Sherlock TLS Stylet IFU (BAW0736702) 
12. PowerGroshong, Sherlock 3CG IFU (BAW0738512) 
13. PowerGroshong, Microintroducer IFU (BAW0748151) 
14. Supplement IFU, PICC and Midline (BAW0728690) 
15. Sherlock 3CG IFU (BAW0741868) 
16. Power Injection Insert (BAW0743752)