Prospective Clinical Evaluation of BD Spinal Needles
Conditions: Analgesia, Anesthesia
Sponsor: Becton, Dickinson and Company

1 of 1 
 
 
Cover Page of study protocol 
 
COVER PAGE OF STUDY PROTOCOL 
 
Study title: 
Prospective Clinical Evaluation of BD Spinal 
Needles  
Protocol number.:
MDS-20EPSPEU001 
 
NCT number:
NCT05214560 
 
Protocol version and date:
v.3.0, 27- April - 2022 
 

Protocol Number: MDS-20EPSPEU001 
 
CONFIDENTIAL 
Version: 3.0 
Date: 27Apr2022 
Page 1 of 37 
 
 
TITLE PAGE 
 
Protocol Title: Prospective Clinical Evaluation of BD Spinal Needles 
 
Protocol Number: MDS-20EPSPEU001 
 
Version Number: 3.0 
 
Study Device: BD Spinal Needles: Quincke Type Point or Whitacre Pencil Point, packaged   
   with or without Introducer 
   
 
Study Type: Prospective, Observational, Post-Market  
 
Sponsor Name:  Becton, Dickinson & Company 
 
Legal Registered Address: 1 Becton Drive,  
Franklin Lakes, New Jersey 07417  
US 
 
Sponsor Contact: 
Gloria Viti 
 
 
 
Clinical Project Manager 
 
 
 
Global Clinical Development 
 
 
 
Becton, Dickinson & Company 
 
 
 
gloria.viti@bd.com 
 
 
 
+39.345.2237718 
 
 
 
 
Version History 
Version Number 
Date 
Type 
3.0 
27 APR 2022 
Administrative changes; 
addition of BD Spinal needles 
2.0 
15 JUL 2021 
Revised study design 
1.0 
31 MAR 2021 
Original 
 
 
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SPONSOR PROTOCOL APPROVAL 
 
 
Signature below indicates approval of the protocol as written. 
Individual or 
function 
Name 
Signature 
Date 
Business Unit 
Medical Affairs 
Edward Maratea 
This document is 
signed electronically 
in the eTMF system 
 
Business Unit 
Regulatory 
Affairs 
John W Roberts 
This document is 
signed electronically 
in the eTMF system 
 
Global Clinical 
Development 
Statistician 
Milan Bimali 
This document is 
signed electronically 
in the eTMF system 
 
Global Clinical 
Development 
Project Manager 
Gloria Viti 
This document is 
signed electronically 
in the eTMF system 
 
 
 
 
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PROTOCOL SIGNATURE 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), 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 procedure, 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 ISO regulations (e.g., ISO 14155). 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 Number 
 
_______________________________________________  
Date  
 
 
 
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PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE 
 
Amendment 3.0 (27Apr2022) 
This amendment is considered to be nonsubstantial based on the criteria set forth in Article 
75 1. of the Regulation (EU) 2017/745 on Medical Devices because it neither significantly 
impacts the safety, or physical/mental integrity of participants nor the scientific value of the 
study. 
 
Overall Rationale for the Amendment:  
The rationale for the amendment is to include other BD spinal needles already available on the 
market with the same gauges listed in the protocol v.2.0, 15Jul2021 but different lengths.  
 
Summary of Change Table 
 
Location of 
Original 
Text 
Original 
Text 
New Text 
Rationale for 
Change 
Header/Title 
Page 
15 Jul 2021 
27 Apr 2022 
Version Control 
Header/Title 
Page 
Version: 2.0  Version: 3.0 
Version Control 
Sponsor 
Protocol 
Approval 
Yang Bai 
Milan Bimali 
Statistician change 
Appendices: 
16.1 BD 
Spinal 
Needles  
N/A 
 
 
 
Quincke 
408360 
18G x 156 mm (6 in.) 
Quincke 
405211 
20 G x 156 mm (6 in.) 
Quincke 
405148 
22 G x 127 mm (5 in.) 
Quincke 
405149 
22 G x 178 mm (7 in.) 
Whitacre 
409442 
25 G x 119 mm (4 
11/16 in.) 
Whitacre 
409443 
27 G x 119 mm (4 
11/16 in.) 
 
 
 
 
Additional BD 
Spinal needles 
with the same 
gauges and 
different lengths, 
already available 
on the market. 
Appendices: 
16.1 BD 
Spinal 
Needles – 
Kit/Set 
needle type 
Kit/Set 
Needle 
Type: 
Whitacre 
Catalog 
Number: 
405112  
Description: 
25 G x 103 
mm (4 1/16 
in.) 
Whitacre 
Set 
N/A 
Clarification: typo 
error. 
Modification: The 
catalog number 
and related 
description have 
been removed 
because they were 
a repetition. 
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Location of 
Original 
Text 
Original 
Text 
New Text 
Rationale for 
Change 
Appendices: 
16.1 BD 
Spinal 
Needles – 
Kit/Set 
needle type 
Kit/Set 
Needle 
Type: 
Whitacre 
Catalog 
Number: 
405113 
Description: 
27 G x 103 
mm (4 1/16 
in.) 
Whitacre 
Set 
N/A 
Clarification: typo 
error. 
Modification: The 
catalog number 
and related 
description have 
been removed 
because they were 
a repetition. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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TITLE PAGE ............................................................................................................................. 1 
Abbreviations ............................................................................................................................. 9 
1 
PROTOCOL SUMMARY ............................................................................................... 10 
1.1 
Synopsis .................................................................................................................... 10 
1.2 
Schedule of Activities ............................................................................................... 13 
2 
INTRODUCTION ........................................................................................................... 14 
2.1 
Background ............................................................................................................... 14 
2.2 
Rationale.................................................................................................................... 14 
2.3 
Risk/Benefit Assessment ........................................................................................... 15 
2.3.1 
Risk Assessment ................................................................................................ 15 
2.3.2 
Benefit Assessment ............................................................................................ 15 
2.3.3 
Overall Benefit: Risk Conclusion ...................................................................... 16 
3 
OBJECTIVES AND ENDPOINTS ................................................................................. 16 
4 
STUDY DESIGN............................................................................................................. 16 
4.1 
Overall Design........................................................................................................... 16 
4.1.1 
Spinal Needle Procedure .................................................................................... 17 
4.2 
Scientific Rationale for Study Design ....................................................................... 17 
4.2.1 
Participant Input into Design ............................................................................. 17 
4.3 
End of Study Definition ............................................................................................ 17 
5 
STUDY POPULATION .................................................................................................. 18 
5.1 
Inclusion Criteria ....................................................................................................... 18 
5.2 
Exclusion Criteria ...................................................................................................... 18 
5.3 
Lifestyle Considerations ............................................................................................ 18 
5.4 
Screen Failures .......................................................................................................... 18 
5.5 
Vulnerable Population ............................................................................................... 18 
6 
STUDY INTERVENTIONS ........................................................................................... 19 
6.1 
Investigational/Test Devices ..................................................................................... 19 
6.2 
Control Device/Standard of Care .............................................................................. 19 
6.3 
Ancillary Devices/Products ....................................................................................... 19 
6.4 
Device Labeling ........................................................................................................ 19 
6.5 
Treatment Allocation and Measures to Minimize Bias ............................................. 20 
7 
STUDY PROCEDURES AND ASSESSMENTS ........................................................... 20 
7.1 
Study duration ........................................................................................................... 20 
7.2 
Screening and Enrollment ......................................................................................... 20 
7.3 
Medical History / Baseline Assessments .................................................................. 20 
7.4 
Neuraxial Procedure .................................................................................................. 21 
7.4.1 
Spinal Needle Procedure .................................................................................... 21 
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7.5 
Ease of Use Procedure Survey .................................................................................. 21 
7.6 
Participant Follow-Up ............................................................................................... 21 
8 
PARTICIPANT DISCONTINUATION/WITHDRAWAL............................................. 22 
8.1 
Discontinuation/Withdrawal ..................................................................................... 22 
8.2 
Lost to Follow-Up ..................................................................................................... 22 
9 
ADVERSE EVENTS AND DEVICE DEFICIENCIES ................................................. 22 
9.1 
Definitions of Events ................................................................................................. 22 
9.1.1 
Adverse Events (AEs) ........................................................................................ 22 
9.1.2 
Serious Adverse Events (SAEs)......................................................................... 23 
9.1.3 
Adverse Device Effect (ADE) / Serious Adverse Device Effect (SADE) ......... 23 
9.1.4 
Unanticipated (Serious) Adverse Device Effect (UADE/USADE) ................... 24 
9.2 
Severity of Adverse Events ....................................................................................... 24 
9.3 
Relationship of Adverse Event to Device(s)/Procedure ............................................ 24 
9.4 
Reporting of Events ................................................................................................... 25 
9.5 
Safety Committees .................................................................................................... 25 
9.6 
Device Deficiencies................................................................................................... 25 
9.7 
Serious Health Threat ................................................................................................ 26 
10 STATISTICAL METHODS ............................................................................................ 26 
10.1 Overview of Study Design ........................................................................................ 27 
10.2 Sample Size Considerations ...................................................................................... 27 
10.3 Analysis Population................................................................................................... 27 
10.4 Primary Endpoints ..................................................................................................... 27 
10.5 Secondary Endpoint(s) .............................................................................................. 27 
10.6 Other Analyses .......................................................................................................... 27 
11 DATA COLLECTION AND RECORD MAINTENANCE ........................................... 28 
11.1 Case Report Forms .................................................................................................... 28 
11.2 Source Documentation .............................................................................................. 28 
11.3 Data Management ..................................................................................................... 28 
11.4 Record Retention ....................................................................................................... 28 
12 QUALITY CONTROL AND ASSURANCE ................................................................. 29 
12.1 Control of Study Products ......................................................................................... 29 
12.2 Monitoring ................................................................................................................. 29 
12.3 Audits and Inspections .............................................................................................. 30 
12.4 Protocol Deviations ................................................................................................... 30 
13 ADMINISTRATIVE REQUIREMENTS ....................................................................... 30 
13.1 Investigator and Site Selection .................................................................................. 30 
13.2 Training ..................................................................................................................... 31 
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13.3 Required Documents ................................................................................................. 31 
13.4 Insurance ................................................................................................................... 31 
13.5 Publication Policy ..................................................................................................... 31 
13.6 Study Registration ..................................................................................................... 32 
13.7 Termination of Study ................................................................................................ 32 
14 ETHICAL AND REGULATORY CONSIDERATIONS ............................................... 33 
14.1 IRB/EC Approval ...................................................................................................... 33 
14.2 Informed Consent and Confidentiality ...................................................................... 33 
14.3 Confidentiality ........................................................................................................... 34 
14.4 Regulatory Status ...................................................................................................... 34 
14.5 Statement of Compliance .......................................................................................... 34 
15 REFERENCES ................................................................................................................ 35 
16 APPENDICES ................................................................................................................. 36 
16.1 BD Spinal Needles .................................................................................................... 36 
 
 
 
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Abbreviations 
 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
BD 
Becton Dickinson and Company 
CFR 
Code of Federal Regulations 
CRF 
Case Report/Record Form 
CSA 
Clinical Study Agreement 
CSF 
Cerebrospinal Fluid 
CV 
Curriculum Vitae 
DMP 
Data Management Plan 
EDC 
Electronic Data Capture 
FDA 
Food and Drug Administration 
FDAAA 
FDA Amendments Act of 2007 
GCP 
Good Clinical Practice 
GDPR 
General Data Protection Regulation 
ICF 
Informed Consent Form 
ICMJE 
International Committee of Medical Journal Editors 
IRB/EC 
Institutional or Independent Review Board/Ethics Committee 
NDA 
Non-Disclosure Agreement 
PDPH 
Post-Dural Puncture Headache 
PI 
Principal Investigator 
RMV 
Routine Monitoring Visit 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SoA 
Schedule of Activities 
SOP 
Standard Operating Procedure 
TMF 
Trial Master File 
 
 
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1 
PROTOCOL SUMMARY 
 
1.1 Synopsis 
 
Protocol Title 
Prospective Clinical Evaluation of BD Spinal Needles 
Rationale 
This study is designed to assess the safety and performance of the 
BD Spinal Needles mainly, but not limited to the purpose of 
providing clinical data required under EU regulation 2017/745.   
Objectives and Endpoints 
 
Objectives 
Endpoints 
Primary Safety 
 
Spinal Needle: Assess the 
incidence of post-dural puncture 
headache (PDPH) 
Percentage of participants with a 
diagnosis of PDPH in the 7 days 
following the anesthesia 
procedure 
Primary Performance 
 
Spinal Needle: Assess the 
incidence of successful needle 
placement 
Percentage of successful needle 
placement in the subarachnoid 
space defined as the appearance 
of cerebrospinal fluid from the 
spinal needle hub 
Secondary 
 
To assess the incidence of any 
needle or procedure-related 
adverse events (other than 
PDPH) 
Incidence of device/procedure-
related adverse events including 
but not limited to: 
• Spinal/epidural hematoma 
• Nerve damage (pain or 
weakness lower extremities) 
• Infection (Meningitis, spinal 
abscess) 
• Pain, skin redness, irritation at 
or near the skin puncture site 
• Backache 
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Protocol Title 
Prospective Clinical Evaluation of BD Spinal Needles 
Design and Overview 
This is a multi-center, prospective, observational, post-market study 
of participants who will receive neuraxial procedures with a BD 
Spinal Needle as part of their routine medical care.  Up to 150 adult 
and pediatric participants will be enrolled in the study.    
 
Participants will be screened against study inclusion/exclusion 
criteria, consented, and enrolled in the study.  After enrollment, the 
participant’s demographic and limited medical history will be 
documented including the reason for the neuraxial procedure.  The 
procedure(s) performed, and device(s) used, will be left to the 
discretion of the participant’s physician investigator. 
 
The participant will be acutely monitored as required for their 
routine medical care and according to site policy.  Complications or 
adverse events (e.g., PDPH) will be monitored for the 7-day period 
after the procedure.  If the participant is discharged from the hospital 
during this time period, follow-up may be performed in a variety of 
ways including by telephone. 
Study Device 
BD Spinal Needles 
 
BD Spinal Needles are used to access anatomical structures in order 
to introduce medicines, image contrast agents, guide wires, or 
catheters.  The BD Whitacre Pencil Point Spinal Needles are 
available in gauges from 22 – 27 and in lengths from 3 ½ inches to 5 
inches.  The BD Quincke Spinal Needles are available in gauges 18 
– 27 and in lengths from 1 inch to 7 inches.  BD Spinal Needles may 
be packed separately, with introducers, or in anesthesia trays. 
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Protocol Title 
Prospective Clinical Evaluation of BD Spinal Needles 
Participants 
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. 
Inclusion Criteria:  
1. Any patient, regardless of age or gender, for which 
the investigator has decided that a neuraxial 
procedure must be performed utilizing BD Spinal 
Needles as part of their routine medical care  
2. Expected to be available for observation through 
the study period (7-days post procedure) 
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.) 
Exclusion Criteria: 
1. Undergoing emergency surgery  
2. Coagulopathy or bleeding disorder for which 
regional anesthesia poses an increased risk 
3. History of neurological impairment or disease of 
the trunk or lower extremities.  
4. Infection at or near the site of needle insertion 
5. Previous spine surgery at the level involved in the 
study procedure 
Intervention(s)/Procedure(s) This is an observational, real-world study in patients who require a 
medical procedure utilizing a BD Spinal Needle.  There are no 
study-specific procedures required for the participant other than 
informed consent and AE monitoring.  Healthcare professionals 
performing the actual neuraxial procedures will complete a short 
survey after each procedure is performed to assess device 
performance. 
Investigational Sites 
Five or more sites located within the European Union 
Study Duration 
Per participant the study will last 7 days at maximum, the overall 
conduct of the study is expected to last approximately 8-10 months 
from first participant enrolled up to last participant having last visit.  
Data Monitoring 
Committee 
A Data Monitoring Committee will not be used in this study. 
Regulatory Status 
All BD devices utilized in this study as part of routine medical care 
are CE marked and commercially available.  As such, this is a post-
market study. 
 
 
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1.2 Schedule of Activities 
Procedure / Study Phase 
Screening/ 
Enrollment 
Insertion 
(Day 0) 
Through Day 7 
Post-Insertion 
Inclusion and Exclusion Criteria 
X 
 
 
Informed Consent 
X 
 
 
Baseline and Demography 
X 
 
 
Limited Medical History 
X 
 
 
Spinal Needle Procedure 
 
X 
 
Procedure-Specific Information 
 
X 
 
Ease of Use Survey 
 
X 
 
AE Monitoring 
 
X 
X 
Device deficiency monitoring 
 
X 
X 
 
 
 
 
 
 
 
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2 
INTRODUCTION 
 
Becton, Dickinson & Company manufactures a variety of devices used in neuraxial 
procedures including spinal needles and associated introducers.  These devices are used 
in medical procedures utilizing well established methods.  
 
 
2.1 Background 
 
Neuraxial procedures may be performed for a variety of reasons including administration 
of medications (i.e., anesthesia; analgesia) and introduction of contrast agents, 
guidewires, or catheters.  Neuraxial anesthesia is used for many indications including 
analgesia or surgical anesthesia for lower abdominal or lower extremity procedures or 
labor and delivery. (1)  Neuraxial procedures are performed by placing a needle between 
vertebrae and injecting medication into the subarachnoid space (for spinal anesthesia; 
Figure 1).  Spinal anesthesia is usually administered as a single injection. (2)   
 
 
Figure 1. Spinal Needle Location (Foto credit: Adobe Stock 378168029) 
 
 
2.2 Rationale 
 
This study is designed to assess the safety and performance of the BD Spinal Needles 
mainly, but not limited to the purpose of providing clinical data required under European 
Union (EU) regulation 2017/745.   
 
 
 
 
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2.3 Risk/Benefit Assessment 
 
In this study, data are generated from participants in which the BD Spinal Needles (BD 
Needles) are being used as indicated in the instructions for use.  Other than scheduled 
follow-up assessments, no additional study-specific procedures are being performed.  
Risks associated with study participation are no different than those the participant would 
encounter as part of their required medical care.  The risks presented in Section 2.3.1 are 
associated with neuraxial procedures/anesthesia and are not unique or specific to the use 
of BD Needles.  
 
2.3.1 Risk Assessment 
 
Potential Risk of Clinical 
Significance 
Summary of Data/Rationale 
for Risk 
Mitigation Strategy 
Study Interventions: BD Spinal Needles 
In spinal procedures, larger 
diameter needles and cutting 
needle tips are both associated 
with an increased risk of post-
dural puncture headache 
(PDPH) 
Clinical literature (3; 4) 
Physicians should select the 
smallest diameter needle 
sufficient to support the specific 
procedure 
Study Procedures 
Neuraxial procedures may be  
associated with the following 
risks: 
• Inadequate or failed anesthesia  
• Hemodynamic changes, most 
commonly hypotension 
• Post-dural puncture headache 
(spinal only) 
• Localized pain 
• Localized skin irritation 
• Urinary retention (temporary) 
• Nerve injury (rare) 
• Spinal-epidural hematoma 
(rare) 
• Infection 
Clinical literature (5; 6; 7; 8; 9) 
• Physicians should select the 
smallest diameter needle 
sufficient to support the 
specific procedure 
• Patient blood pressure and 
heart rate should be closely 
monitored throughout the 
procedure and after medication 
administration 
• Only physicians with sufficient 
training and experience should 
perform neuraxial anesthesia 
procedures 
Other 
Not applicable 
 
 
 
 
2.3.2 Benefit Assessment 
 
There are no direct benefits to participants in the study. 
 
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2.3.3 Overall Benefit: Risk Conclusion 
 
Due to the observational nature of this study, there is no anticipated benefit to an 
individual participant.  Likewise, because a participant will undergo a spinal 
needle procedure regardless of their participation in the study, there are no 
anticipated study-specific risks.   
 
 
3 
OBJECTIVES AND ENDPOINTS 
 
Objectives 
Endpoints 
Primary Safety 
 
Spinal Needle: Assess the incidence of post-
dural puncture headache (PDPH) 
Percentage of participants with a diagnosis of 
PDPH in the 7 days following the anesthesia 
procedure 
 
Primary Performance 
 
Spinal Needle: Assess the incidence of 
successful needle placement 
Percentage of successful needle placement in 
the subarachnoid space defined as the 
appearance of cerebrospinal fluid from the 
spinal needle hub 
Secondary 
 
To assess the incidence of any needle or 
procedure-related adverse events (other than 
PDPH) 
Incidence of device/procedure-related adverse 
events including but not limited to: 
• Spinal/epidural hematoma 
• Nerve damage (pain or weakness lower 
extremities) 
• Infection (Meningitis, spinal abscess) 
• Pain, skin redness, irritation at or near the 
skin puncture site 
• Backache 
 
  
4 
STUDY DESIGN 
 
4.1 Overall Design 
 
This is a multi-center, prospective, observational, post-market study of participants who 
will receive neuraxial procedures with a BD Spinal Needle as part of their routine 
medical care.  Up to 150 adult and pediatric participants will be enrolled in the study.    
 
Participants will be screened against study inclusion/exclusion criteria, consented, and 
enrolled in the study.  After enrollment, the participant’s demographic and limited 
medical history will be documented including the reason for the neuraxial procedure.   
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The procedure(s) performed, and device(s) used, will be left to the discretion of the 
participant’s physician investigator.   
 
4.1.1 Spinal Needle Procedure 
 
The physician investigator will perform the spinal needle procedure (to introduce 
medications or image contrast agents) based on the medical needs of the 
participant.  The physician investigator will choose the vertebral interspace, 
participant position, procedure/ technique, and BD spinal needles.  The participant 
will be monitored closely at regular intervals per practice guidelines and site 
policies.   
 
The physician investigator will document the procedure in a standard procedure 
note.  The note should include but is not limited to the equipment/devices used, 
participant position, interspace level, number of attempts, and any identified 
complication or adverse event.  If used, spinal medications with amounts will also 
be documented.  After the procedure is completed, the physician investigator will 
complete a short ease of use survey regarding the performance of the devices 
used. 
 
The participant will be acutely monitored as required for their routine medical 
care and according to site policy.  Complications or adverse events (e.g., PDPH) 
will be monitored for the 7-day period after the procedure.  If the participant is 
discharged from the hospital during this time period, follow-up may be performed 
in a variety of ways including by telephone. 
 
 
4.2 Scientific Rationale for Study Design 
 
This study is designed to assess the real-world safety and efficacy of BD Spinal Needles 
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 
 
Not applicable. 
 
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 the 7-day post-procedure follow-up assessment.   
 
The end of the study is defined as the date of the last study assessment of the last 
participant in the study. 
 
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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: 
 
1. Any patient, regardless of age or gender, for which the investigator has decided that a 
neuraxial procedure must be performed utilizing BD Spinal Needles as part of their 
routine medical care  
2. Expected to be available for observation through the study period (7-days post 
procedure) 
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. Undergoing emergency surgery  
2. Coagulopathy or bleeding disorder for which regional anesthesia poses an increased 
risk 
3. History of neurological impairment or disease of the trunk or lower extremities.  
4. Infection at or near the site of needle insertion 
5. Previous spine surgery at the level involved in the study procedure 
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.  
 
5.5 Vulnerable Population 
  
As the instruction for use of the BD Spinal Needles do not foresee any limitations in 
terms of subject age or status and the study aims to collect observational data on clinical 
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use, the study will also consider participants under 18 years of age, or participants 
requiring a legal authorized representative. Also pregnant and breastfeeding subjects 
aren’t excluded from study participation. As the study device will be used as intended, 
this population is considered to be not exposed to any additional risk due to the study 
participation. 
 
Some participating clinical sites may decide to not include vulnerable subjects as per 
their hospital policy or may not include minors as the participating department treats only 
adults. 
 
 
6 
STUDY INTERVENTIONS 
 
6.1 Investigational/Test Devices 
 
BD Spinal Needles are used to access anatomical structures in order to introduce 
medicines, image contrast agents, guide wires, or catheters.  The BD Whitacre Pencil 
Point Spinal Needles are available in gauges from 22 – 27 in a 3½ inch length.  The BD 
Quincke Spinal Needles are available in gauges 18 – 27 and in lengths from 1½  inch to 
3½ inches.  BD Spinal Needles may be packed separately, with introducers, or in 
anesthesia trays.  See Appendix 16.1 for a list of BD Spinal Needles included in this 
study. 
 
6.2 Control Device/Standard of Care 
 
This is a single-arm study; no control device(s) will be used. 
 
6.3 Ancillary Devices/Products 
 
Neuraxial procedures are conducted under strict aseptic technique and require the 
physician to wear cap, mask, sterile gloves, and optional sterile gown.  The site will be 
covered with a sterile drape and prepped with an appropriate antiseptic agent.  Materials 
used to comply with aseptic technique will be provided by the site according to their site-
specific requirements. 
 
Use of additional devices may be required depending on the procedure being performed.  
If an ancillary device used is a BD device (e.g., spinal needle introducer) information on 
their performance will be captured as part of the ease-of-use survey. 
 
6.4 Device Labeling 
 
This is a post-market study in which devices are used in an on-label fashion.  Sites will 
utilize shelf-stock devices as routinely labeled by the manufacturer. 
 
 
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6.5 Treatment Allocation and Measures to Minimize Bias 
 
This is a real-world study in which study devices are used as part of the required medical 
care for participants.  The choice of the specific device is left to the discretion of the 
clinician. 
All patients potentially fulfilling the inclusion/exclusion criteria will be sequentially 
offered participation in this study when they attend for a clinical visit prior to 
performance of neuraxial procedure. This rule will allow to avoid any selection bias, 
since all the patients will be proposed the study in chronological order when they attend a 
regular clinic visit. 
 
7 
STUDY PROCEDURES AND ASSESSMENTS 
 
• Study activities procedures 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.  
• Procedures conducted as part of the participant’s routine clinical management (e.g., 
blood count) and obtained before signing of the ICF may be utilized for screening or 
baseline purposes provided the procedures met the protocol-specified criteria and 
were performed within the time frame defined in the SoA. 
 
7.1 Study duration 
 
The study duration per participant will last 7 days at maximum, the overall conduct of the 
study is expected to last approximately 8-10 months from first participant enrolled up to 
last participant having last visit.  
 
7.2 Screening and Enrollment 
 
After screening against inclusion/exclusion criteria, potential participants will be 
provided with detailed information about the study.  For details on the Informed Consent 
process, please refer to section 14.2.  A participant will be considered enrolled once 
informed consent (including assent as applicable) is signed. Enrolled participants will be 
assigned a unique participant number. 
 
7.3 Medical History / Baseline Assessments 
 
After enrollment, participant baseline and demographic information will be documented, 
including, but not limited to:  
• Age 
• Gender 
• Height and Weight (for calculated body mass index) 
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• Primary diagnosis 
• Limited medical history (e.g., surgical history, anticoagulant therapy) 
• ASA Class (I, II, III, IV) (if appropriate) 
• Reason for neuraxial procedure 
 
7.4 Neuraxial Procedure 
 
Choice of the specific BD Spinal Needle, gauge, and length required for an individual 
participant is left to the discretion of the clinician.  The device, participant, and insertion 
site will be prepared according to standard medical practices and site-specific procedures.  
The device will be inserted, its location confirmed, and the device utilized according to 
the specific medical needs of the participant and site-specific protocols and procedures.   
 
7.4.1 Spinal Needle Procedure 
 
After the spinal needle procedure is performed, information about the insertion 
procedure will be documented, including, but not limited to: 
• Date and time of insertion 
• Participant position 
• Use of aseptic technique 
• Use of local anesthesia 
• Interspace 
• Needle type, gauge, and length 
• Introducer (if used) 
• Number of insertion attempts (including interspace levels) 
• Medications/agents injected (type, dose, volume) (if appropriate) 
• Maximum spinal block level measured (left and right) ( if appropriate) 
• Adverse events/complications (including but not limited to study endpoints)  
• Device deficiencies/failures  
• Physician performing procedure experience (e.g., years of experience, 
estimated number of spinal needle procedures performed) 
 
 
7.5 Ease of Use Procedure Survey 
 
After the neuraxial procedure data is recorded, the physician investigator will complete a 
short survey to assess the performance of the BD devices used in the procedure.   
 
7.6 Participant Follow-Up 
 
Participants will be followed through 7-days post procedure to assess for adverse 
events/complications.  Assessments may be performed in a variety of ways, including by 
telephone, if the participant has been discharged from the hospital prior to day-7 post 
procedure.  Additional information may also be collected if appropriate. 
 
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During the required follow-up period the following data will be collected: 
• Incidence of device/procedure-related adverse events including but not 
limited to, 
o Spinal/epidural hematoma 
o Nerve damage (pain or weakness lower extremities) 
o Infection (Meningitis, spinal abscess) 
o Pain, skin redness, irritation at or near the skin puncture site 
o Backache 
• Incidence of post-dural puncture headache, including grading as follows, 
o 0: No headache 
o 1: Mild headache, not interference with daily activities 
o 2: Moderate headache, some interference with daily activities 
o 3: Severe headache, bedridden 
o 4: Severe headache, requires hospitalization or prolonged 
hospitalization 
 
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 day-7 post 
procedure follow-up) may be replaced. 
 
8.2 Lost to Follow-Up 
 
A participant will be considered lost to follow-up if he or she repeatedly is unable to be 
contacted by the study site. 
 
 
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 
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participants, users or other persons, whether or not related to study device and 
whether anticipated or unanticipated (ISO 14155:2020).  In this study, AE 
collection will be limited to those events judged by the investigator to be related 
or likely related to the neuraxial procedure and/or the BD Spinal Needles used in 
the procedure. 
 
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. Likewise, planned hospital visits and/or hospital stays should not be 
considered as adverse events.  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 14155:2020 as an adverse event that 
led to any of the following:  
a. death;  
b. serious deterioration in health of the participant, 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 disease, or 
3. in-patient hospitalization 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. fetal distress, fetal death, a congenital abnormality or birth defect 
including physical or mental impairment. 
 
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, installation, 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. 
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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. 
 
UADEs/USADEs will be reported to the appropriate governing body per ISO 
14155:2020. 
 
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 
 
 
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 in the neuraxial access procedure. 
 
• Procedure:  A procedure includes any study-related activity performed during the 
neuraxial procedure. 
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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 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. 
 
It is the responsibility of the Investigator to report adverse events to individual 
Institutional Review Boards (IRBs)/Ethics Committees (ECs) and/or regulatory 
authorities according to the local regulations in each participating country. 
 
9.5 Safety Committees 
 
A safety committee will not be used in this study. 
 
 
9.6 Device Deficiencies 
 
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The Investigator will record a device deficiency if a device used in the study, which is or 
appears to be inadequate with respect to its identity, quality, durability, reliability 
usability, safety or performance due to mechanical failure, malfunction, or defect.  
Device deficiencies also include use errors and inadequacy in the information supplied by 
the manufacturer including 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 procedure/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 as outlined in 
the site’s regulatory binder 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 under 21 CFR part 803 Medical 
Device Reporting by the Sponsor if necessary, or 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 to notify the IRB/EC of such device deficiencies 
in accordance with the IRB/EC and/or the Competent Authority’s local regulations. 
 
 
9.7 Serious Health Threat 
 
During the course of the study, device deficiencies or adverse events will be assessed if 
they constitute a serious health threat. The serious health threat is a signal from any 
adverse event or device deficiency that indicates an imminent risk of death or a 
serious deterioration in the health of subjects, users or other persons, and that requires 
prompt remedial action for other subjects, users or other persons. Serious health threat 
includes the possibility of multiple deaths occurring at short intervals, or other significant 
and unexpected serious adverse events that can be regarded as a potential serious health 
hazard in subjects, users or other persons and which are possibly related to the 
investigation device use. 
 
10 STATISTICAL METHODS 
 
The statistical analysis plan will be finalized prior to database lock 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 primary 
and secondary endpoints. 
 
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10.1 Overview of Study Design 
 
This is a multi-center, prospective, observational study to assess the overall safety and 
performance of the BD Spinal Needles. 
   
10.2 Sample Size Considerations 
 
The primary safety endpoint for spinal needles is the incidence of PDPH with an 
expected rate ranging from 0.3% to 3% based on literature review.  With an incidence of 
PDPH of 3%, a sample size of 150 participants would lead to a precision of estimate less 
than 5% using Clopper Pearson exact method (precision of estimate is the distance 
between point estimate to the upper bound of 95% two-sided exact confidence interval). 
Additionally, with a sample size of 150 participants, the probability of observing at least 
one PDPH with is 91.1% when the expected rate of PDPH is 1.6%. 
 
The primary efficacy endpoint for spinal needles is successful placement, defined as the 
spontaneous appearance of CSF, with an expected rate ranging from 90% to 100% based 
on literature review.  With an expected placement success rate of 90%, a sample size of 
150 participants would lead to a precision of estimate at approximately 5% using 
Clopper Pearson exact method.  
 
10.3 Analysis Population 
 
The following populations are defined: 
Population 
Description 
Enrolled  
All participants who sign the ICF 
Evaluable 
All participants in whom a neuraxial procedure is attempted, 
regardless of success 
 
10.4 Primary Endpoints 
 
The incidence rate for the primary safety endpoints will be calculated as the number of 
participants experiencing the event divided by the total number of evaluable patients; 
95% confidence interval (exact method) will be calculated.  The same approach will be 
used for primary efficacy endpoints. 
 
10.5 Secondary Endpoint(s) 
 
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. 
 
10.6 Other Analyses 
 
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For other data not specifically captured under primary or secondary endpoints (e.g., 
participant position; medications administered), 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). 
 
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. 
 
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.   
 
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 
recording, data tracking, data review, database cleaning, issuing/resolving data queries 
and securing of electronic data system as well as the 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 ten (10) 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 
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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 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.   
 
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 Monitor 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 Monitor will conduct a final close-out visit (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, ensuring that all 
applicable requirements for closure of the study are met.  
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12.3 Audits and Inspections 
 
If the study is selected for audit by the Sponsor or if there is an inspection by the 
appropriate Health Authorities, the Investigator and her/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 Health 
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 
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, when a protocol deviation is planned or anticipated, 
the Sponsor should be contacted for 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. 
 
 
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 
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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 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, study 
requirements and if needed study devices 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; 
• 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 Protocol Signature Page by PI; 
• 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 Insurance 
 
Where required by local regulation, insurance coverage will be provided by BD for study 
participants. 
 
13.5 Publication Policy 
 
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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. 
 
13.6 Study Registration 
 
While this is a non-interventional study and does not meet the FDA Amendments Act of 
2007 (FDAAA) criteria for clinical study registration, the study will be registered on 
www.clinicaltrials.gov.  The Sponsor will register the study on local registries if 
applicable. The content of the publicly accessible database(s) will be updated throughout 
the conduct of the clinical study and the results will be entered after study completion in 
order to made publicly available the results of the study. 
 
 
13.7 Termination of Study 
 
The Sponsor reserves the right to suspend enrollment or terminate the study at any time 
for any reason.  If suspicion of an unacceptable risk, including serious health threat to 
subjects, arises during the study, the Sponsor may suspend the study while the risk is 
assessed. The sponsor shall terminate the clinical investigation if an unacceptable risk 
which cannot be controlled is confirmed.  
 
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.  
 
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.  
 
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14 ETHICAL AND REGULATORY CONSIDERATIONS 
 
14.1 IRB/EC Approval 
 
Investigators or designees must submit the study protocol, Informed Consent 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, 
if applicable per local regulations. 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, the 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., 
General Data Protection Regulation [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 by 
signing the form, including date and time of signature, in accordance with ISO 14155.  
The participant* will receive a copy of his/her signed ICF. The informed consent process 
should be documented in the participant’s medical record. 
 
*Note: If the participant is under the age of 18 years, participants’ parent(s) or legal 
guardian must provide their informed consent and the child must provide assent, 
depending on local EC requirements, by personally signing and dating the respective 
consent form prior to begin of this study.  
 
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14.3 Confidentiality 
 
Participant confidentiality must be strictly held in trust by the Investigator, study staff, 
and the Sponsor.  Participant confidentiality and anonymity will be 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 Monitor, 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.  
 
14.4 Regulatory Status 
 
The study devices are CE marked and will be studied in a post-market fashion in Europe. 
 
 
14.5 Statement of Compliance 
 
This clinical investigation will be conducted in compliance with the protocol and 
following regulatory requirements: 
• ISO14155:2020 (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. Ituk U, Wong, CA.  Overview of neuraxial anesthesia.  UpToDate. 
https://www.uptodate.com/contents/overview-of-neuraxial-
anesthesia?search=neuraxial%20anesthesia&source=search_result&selectedTitle=1~
150&usage_type=default&display_rank=1  Accessed February 2021. 
2. DeLeon AM, Wong CA.  Spinal anesthesia: Technique.  UpToDate.  
https://www.uptodate.com/contents/spinal-anesthesia-
technique?search=neuraxial%20anesthesia&source=search_result&selectedTitle=5~1
50&usage_type=default&display_rank=5  Accessed February 2021. 
3. Fama F, Linard C, Bierlaire D, Gioffre-Florio M, Fusciardi J, Laffon M. Influence of 
needle diameter on spinal anaesthesia puncture failures for caesarean section: A 
prospective, randomised, experimental study. Anaesth Crit Care Pain Med. 
2015;34(3015):277-80. 
4. Apfelbaum JL, Hawkins JL, Agarkar M, Bucklin BA, Connis RT, Gambling DR, et 
al. Practice guidelines for obstetric anesthesia: an updated report by the American 
Society of Anesthesiologists Task Force on Obstetric Anesthesia. Anesthesiology. 
2007;106(4):843-63. 
5. Back Pain Tekgul, Z.T., et al., Acute Back Pain Following Surgery under Spinal 
Anesthesia. Pain Pract, 2015. 15(8): p. 706-11.  
6. Urinary Retention Prakash, D., et al., Local anaesthesia versus spinal anaesthesia in 
inguinal hernia repair: A systematic review and meta-analysis. The Surgeon, 2017. 
15(1): p.47-57. 
7. Spinal Hematoma, Urinary Retention, Hypotension Hinarejos, P., et al., Local 
infiltration analgesia adds no clinical benefit in pain control to peripheral nerve 
blocks after total knee arthroplasty. Knee Surgery, Sports Traumatology, 
Arthroscopy, 2016. 24(10): p. 3299-3305. 
8. Subdural Hematoma Moradi, M., et al., Cerebral Subdural Hematoma Following 
Spinal Anesthesia: Report of Two Cases. Case Reports in Medicine, 2012. 2012: p. 
352028. 
9. Spinal Hematoma and Abscess (Infection) 1 Bos, E., et al., Haematoma and abscess 
after neuraxial anaesthesia: a review of 647 cases. British journal of anaesthesia, 
2018. 
 
 
 
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16 APPENDICES 
 
16.1 BD Spinal Needles 
 
Needle Type 
Catalog Number 
Description 
Whitacre 
401995 
22 G x 90 mm (3 1/2 in.) 
Whitacre 
405104 
24 G x 90 mm (3 1/2 in.), Thin Wall 
Whitacre 
402050 
25 G x 90 mm (3 1/2 in.), Thin Wall 
Whitacre 
402051 
27 G x 90 mm (3 1/2 in.) 
Quincke 
405247 
18 G x 75 mm (3 in.)   
 
Quincke 
405248 
18 G x 90 mm (3 1/2 in.)  
 
Quincke 
405249 
19 G x 75 mm (3 in.)   
Quincke 
405250 
19 G x 90 mm (3 1/2 in.)  
 
Quincke 
405251 
20 G x 38 mm (1 1/2 in.)  
Quincke 
405252 
20 G x 75 mm (3 in.)   
Quincke 
405253 
20 G x 90 mm (3 1/2 in.)  
 
Quincke 
405254 
22 G x 38 mm (1 1/2 in.)  
 
Quincke 
405244 
22 G x 64 mm (2 1/2 in.)  
 
Quincke 
405255 
22 G x 75 mm (3 in.)   
Quincke 
405256 
22 G x 90 mm (3 1/2 in.)  
 
 
 
Quincke 
405240 
23 G x 90 mm (3 1/2 in.)  
 
 
Quincke 
405245 
25 G x 51 mm (2 in.)   
 
Quincke 
405257 
25 G x 90 mm (3 1/2 in.)  
 
Quincke 
405246 
25G x 75 mm (3.5 in.) 
Quincke 
405234 
25 G x 119 mm (4 11/16 in.)   
Quincke 
405258 
26 G x 90 mm (3 1/2 in.)  
 
 
Quincke 
405259 
27 G x 90 mm (3 1/2 in.)  
 
Quincke 
405243 
25 G x 25 mm (1 in.), Neonatal Lumbar 
Quincke 
408360 
18G x 156 mm (6 in.) 
Quincke 
405211 
20 G x 156 mm (6 in.) 
Quincke 
405148 
22 G x 127 mm (5 in.) 
Quincke 
405149 
22 G x 178 mm (7 in.) 
Whitacre 
409442 
25 G x 119 mm (4 11/16 in.) 
Whitacre 
409443 
27 G x 119 mm (4 11/16 in.) 
 
 
 
 
 
 
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Kit/Set 
Needle Type 
Catalog 
Number 
Description 
Whitacre 
405076 
25 G x 90 mm BD™ Whitacre spinal needle, Thin Wall  
Whitacre 
405075 
27 G x 90 mm BD™ Whitacre spinal needle  
 
Whitacre 
405112 
25 G x 103 mm (4-1/16 in.) Whitacre Set 
Whitacre 
405113 
27 G x 103 mm (4 1/16 in.) Whitacre Set 
Quincke 
405084 
25 G x 90 mm BD™ Quincke spinal needle   
Quincke 
405065 
26 G x 90 mm BD™ Quincke spinal needle   
Quincke 
405069 
27 G x 90 mm BD™ Quincke spinal needle   
Quincke 
405068 
29 G x 90 mm (3 1/2 in.)  Spinal Set 
 
 
 
 
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Signature Page for VV-TMF-247774 v1.0
Signature Page for VV-TMF-247774 v1.0
Reason for signing: Finalize
Name: Gloria Viti
Role: Clinical Project Management
Date of signature: 27-Apr-2022 12:09:58
GMT+0000
Reason for signing: Finalize
Name: Edward Maratea
Role: Medical Monitor
Date of signature: 27-Apr-2022 18:28:40
GMT+0000
Reason for signing: Finalize
Name: John Roberts
Role: Regulatory Affairs
Date of signature: 29-Apr-2022 16:15:12
GMT+0000
Reason for signing: Finalize
Name: Milan Bimali
Role: Statistics & Programming
Date of signature: 29-Apr-2022 17:12:31
GMT+0000
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