An Open-Label, Parallel, Randomized Study to Evaluate the Performance of Needle Placements for Diagnostic and Therapeutic Neuraxial Procedures, Using a Handheld Tactile Imaging-based Method Versus Palpation
Phase: NA
Conditions: Central Nervous System Infections, Pseudotumor Cerebri, Neurological Disorder, Cancer, Obstetric Procedure Pain, Orthopedic Procedure Pain, Post-Dural Puncture Headache
Sponsor: IntuiTap Medical, Inc

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
An Open-Label, Parallel, Randomized Study to Evaluate the Performance of 
Needle Placements for Diagnostic and Therapeutic Neuraxial Procedures, Using a 
Handheld Tactile Imaging-based Method Versus Palpation 
 
NCT04796935 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Document Type: Protocol 
 
Document Date: November 25, 2020 

 
 
An Open-Label, Parallel, Randomized Study to Evaluate the 
Performance of Needle Placements for Diagnostic and Therapeutic 
Neuraxial Procedures, Using a Handheld Tactile Imaging-based Method 
Versus Palpation 
Version 2 / 25 November 2020 
 
Regulatory Sponsor:  
IntuiTap Medical, Inc. 
 
2450 Holcombe Blvd, Suite J 
 
Houston, TX  77021 
 
 
 
 
Jessica Traver 
 
Chief Executive Officer 
 
Phone: 626-222-2202 
Protocol Identifiers: 
INT-001 
Study Type: 
Multi-center, Randomized, Superiority Study 
Study Product: 
VerTouchTM 
 
 
CONFIDENTIAL 
This document is confidential and the property of the IntuiTap Medical, Inc.   

IntuiTap Medical                                                                                                                 CONFIDENTIAL 
 
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Statement of Compliance 
This document is a protocol for a human research study. This study will be conducted 
according to US and International standards of Good Clinical Practice, applicable 
government regulations and Institutional research policies and procedures.   
All individuals responsible for the design and conduct of this study have completed 
Human Subjects Protection Training and are qualified to be conducting this research prior 
to the enrollment of any subjects.   
As Principal Investigator, I agree to conduct this clinical study in accordance with the 
design and specific provisions of this protocol. Modifications to the study are acceptable 
only with an approved protocol amendment. I agree to obtain approval from the IRB 
and/or regulatory bodies of competent jurisdiction, for the protocol and informed consent 
before initiating the study, to obtain consent from subjects prior to their enrollment in the 
study, to collect and record data as required by this protocol and case report forms, to 
prepare adverse event and study reports as required by this protocol and to maintain study 
documentation for the period of time required. 
 
 
________________________________________________ 
_________________ 
[Print Name/Title of Principal Investigator]  
 
 
Date 
 
 
As a Sub-Investigator, I agree to conduct this clinical study in accordance with the design 
and specific provisions of this protocol. Modifications to the study are acceptable only 
with an approved protocol amendment. I agree to obtain approval from the IRB and/or 
regulatory bodies of competent jurisdiction, for the protocol and informed consent before 
initiating the study, to obtain consent from subjects prior to their enrollment in the study, 
to collect and record data as required by this protocol and case report forms, to prepare 
adverse event and study reports as required by this protocol and to maintain study 
documentation for the period of time required. 
 
________________________________________________ 
_________________ 
[Print Name/Title of Sub- Investigator] 
 
 
 
 
Date 
[Print Location if multi-site protocol] 
 
 
________________________________________________ 
_________________ 
[Print Name/Title of Sub- Investigator] 
 
 
 
 
Date 
[Print Location if multi-site protocol] 
[Add additional sheets as necessary] 
 

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Version History 
Version # 
Approval 
Date 
Significant Changes from Previous Version 
Version1 
26 Aug 2020 
Original Protocol Version 
Version 2 
25 Nov 2020 
Incorporate changes based on FDA pre-submission 
feedback  
 
 
 
 
 
 
 
 

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Table of Contents 
 
Statement of Compliance .................................................................................................... 2 
Version History ................................................................................................................... 3 
Study Synopsis .................................................................................................................... 7 
Abbreviations .................................................................................................................... 11 
1 Study Contact Information .......................................................................................... 12 
1.1 Sponsor Contact Information ............................................................................... 12 
1.2 Key Study Personnel ............................................................................................ 12 
1.2.1 Clinical Coordinator ....................................................................................... 12 
1.2.2 Clinical Study Monitor .................................................................................. 12 
1.2.3 Medical Monitor ............................................................................................ 12 
1.2.4 Statistician ...................................................................................................... 12 
2 Introduction / Background and Rationale ................................................................... 12 
2.1 Background .......................................................................................................... 12 
2.2 Rationale ............................................................................................................... 14 
3 Device Description ..................................................................................................... 14 
3.1 Assembly .............................................................................................................. 15 
3.2 Workflow Selection .............................................................................................. 15 
3.3 Device Placement ................................................................................................. 16 
3.4 Imaging ................................................................................................................. 16 
3.5 Insertion ................................................................................................................ 17 
3.6 Disassembly .......................................................................................................... 18 
3.7 Monitor Maintenance ........................................................................................... 18 
3.8 Maintenance Mode ............................................................................................... 19 
3.9 User and Subject Characteristics .......................................................................... 19 
3.10 Intended Use ....................................................................................................... 20 
4 Device Accountability ................................................................................................ 20 
4.1 Device Receipt ..................................................................................................... 20 
4.2 Device Storage ..................................................................................................... 20 
4.3 Device Dispensing ................................................................................................ 20 
4.4 Device Disposition ............................................................................................... 21 
4.5 Return or Destruction of Unused Devices ............................................................ 21 
5 Study Objectives ......................................................................................................... 21 
6 Study Design ............................................................................................................... 21 
6.1 Overview of Study Design ................................................................................... 21 
6.2 Anticipated Duration of the Clinical Investigation .............................................. 23 
6.3 Evaluation Criteria / Effectiveness and Safety ..................................................... 23 
6.3.1 Primary Clinical Endpoint ............................................................................. 23 
6.3.2 Secondary Clinical Endpoint(s) ..................................................................... 23 
6.3.3 Tertiary Endpoints ......................................................................................... 24 
6.3.4 Safety Endpoints ............................................................................................ 24 
6.3.5 Exploratory Endpoints ................................................................................... 24 
6.4 Study Population .................................................................................................. 25 
6.4.1 Sample Size .................................................................................................... 25 

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6.4.2 Subject Recruitment ....................................................................................... 26 
6.4.3 Subject Screening ........................................................................................... 26 
6.4.4 Prior and Concomitant Medications .............................................................. 26 
6.4.5 Inclusion Criteria ........................................................................................... 26 
6.4.6 Exclusion Criteria .......................................................................................... 27 
6.4.7 Exit / Discontinuation Criteria ....................................................................... 27 
7 Study Procedures ........................................................................................................ 27 
7.1 Informed Consent ................................................................................................. 27 
7.2 Vulnerable Populations ........................................................................................ 28 
7.3 Randomization Scheme ........................................................................................ 28 
7.4 Clinical Procedures ............................................................................................... 28 
7.4.1 Visit 1 ............................................................................................................. 28 
7.4.2 Visit 2 ............................................................................................................. 31 
7.5 Follow-Up Procedures and Therapy Transitions .................................................. 32 
7.6 Study Timetable / Schedule of Events ................................................................. 32 
7.7 Deviations from the Clinical Protocol .................................................................. 32 
7.8 Subject Withdrawal .............................................................................................. 33 
7.9 Subject Compensation .......................................................................................... 33 
8 Data Collection and Analysis ..................................................................................... 33 
8.1 Subject Population(s) for Analysis ....................................................................... 33 
8.2 Statistical Methods ............................................................................................... 33 
8.2.1 Adjustments for Multiplicity .......................................................................... 34 
8.2.2 Primary Effectiveness Analysis ..................................................................... 35 
8.2.3 Additional Analyses ....................................................................................... 37 
8.2.4 Safety Analyses .............................................................................................. 37 
9 Safety and Adverse Events ......................................................................................... 37 
9.1 Definitions ............................................................................................................ 37 
9.2 Safety Monitoring Plan ........................................................................................ 40 
9.2.1 Anticipated Risks / Risk Mitigation ............................................................... 40 
9.2.2 Medical Monitoring for Participant Safety .................................................... 43 
9.3 Anticipated Adverse Events ................................................................................. 44 
9.4 Adverse Event Reporting ..................................................................................... 45 
9.4.1 Adverse Events .............................................................................................. 45 
9.4.2 Serious Adverse Events ................................................................................. 46 
9.4.3 Unanticipated Adverse Device Effects (UADE) ........................................... 47 
10 Classification as Non-Significant Risk Study ........................................................... 47 
11 Data Handling and Record Keeping ......................................................................... 48 
11.1 Confidentiality .................................................................................................... 48 
11.2 Source Documents .............................................................................................. 48 
11.3 Case Report Forms ............................................................................................. 49 
11.4 Clinical Reports .................................................................................................. 49 
11.5 Records Retention .............................................................................................. 49 
12 Study Monitoring, Auditing, and Inspecting ............................................................ 49 
12.1 Study Monitoring Plan ....................................................................................... 50 
12.2 Auditing and Inspection ..................................................................................... 50 
13 Administrative Study Information ............................................................................ 50 

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13.1 Technical Support ............................................................................................... 50 
13.2 Pre-Study Site Qualification ............................................................................... 51 
13.3 Protocol Amendments After Study Initiation ..................................................... 51 
13.4 Materials / Services Provided by Sponsor and Coordinating Center ................. 51 
14 Ethical Considerations .............................................................................................. 51 
15 Study Finances .......................................................................................................... 52 
15.1 Funding Source ................................................................................................... 52 
15.2 Conflicts of Interest ............................................................................................ 52 
16 Publication Plan ........................................................................................................ 52 
17 References ................................................................................................................. 52 
18 Appendices and Attachments .................................................................................... 56 
18.1 Subject Discomfort During Landmarking .......................................................... 56 
18.2 Provider Confidence ........................................................................................... 56 
 
 
 
 
 

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Study Synopsis 
Title 
An Open-Label, Parallel, Randomized Study to Evaluate the 
Performance of Needle Placements for Diagnostic and 
Therapeutic Neuraxial Procedures, Using a Handheld Tactile 
Imaging-based Method Versus Palpation 
Short Title 
Study to Evaluate the Performance of Needle Placements for 
Diagnostic and Therapeutic Neuraxial Procedures 
Protocol 
Numbers 
INT-001 
Study Sponsor 
IntuiTap Medical, Inc. 
Study 
Classification 
FDA has determined that the study may proceed under the NSR 
provisions of the IDE regulation 
Study Design 
An open-label, parallel, randomized study design 
Study Duration 
Study duration is anticipated to be approximately 4 months 
Study Center(s) 
Approximately 3 sites in the United States 
Objectives 
The primary objective of this study is to establish the superiority 
of VerTouch versus the conventional palpation technique for the 
number of insertion attempts required in diagnostic and 
therapeutic neuraxial procedures. 
Number of 
Subjects 
It is expected that approximately 120 subjects will be screened to 
meet a target enrollment goal of 96 subjects. 
Main Inclusion / 
Exclusion 
Criteria 
Inclusion Criteria 
1. Males and females aged 18 years and above, inclusive  
2. Subjects scheduled for one of the following procedures: 
• Diagnostic LP (collection of CSF and/or 
measurement of ICP to diagnose hemorrhaging or 
neurological infections) 
• Therapeutic 
LP 
(intrathecal 
injection 
of 
therapeutic agents; drainage of CSF to treat 
pseudotumor cerebri) 
• Planned orthopedic or obstetric procedure, such 
as 
labor/induction, 
cesarean 
section, 

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hysterectomy, or total hip/knee replacement, with 
neuraxial anesthesia (injection of anesthetic into 
spinal and/or epidural space to reduce pain during 
procedure)  
• Epidural blood patch (use of autologous blood to 
close holes in the dura mater and relieve PDPH) 
3. Subjects having a BMI ≤42kg/m2 
Exclusion Criteria 
1. Patient does not provide informed consent 
2. Skin or soft tissue infection near the puncture site 
3. Allergy to local anesthetic 
4. Uncorrected coagulopathy 
5. Acute spinal cord trauma 
6. History of lumbar spinal surgery 
7. Prior known failed neuraxial anesthesia 
8. Diagnosed scoliosis, thoracic kyphosis, lumbar lordosis, 
scleroderma, or ankylosing spondylitis, or lumbar spinal 
stenosis 
9. Incarcerated subjects 
 
Study Device 
VerTouchTM 
Duration of 
Device Exposure 
< 2 hours 
Reference 
Therapy 
Conventional palpation technique used for spinal needle 
placement 
Endpoints 
Primary Endpoint: 
The number of insertion attempts (any forward movement of the 
needle following puncture of the skin) in the study device group 
as compared to the control group (palpation). Attempts are 
counted until confirmation of spinal canal access can be assessed. 
Secondary Endpoints: 
1. Incidence of first-insertion success (a case that does not 
require any reinsertions, but can include any number of 
redirections) 
2. Number of redirections (any forward movement of the 

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needle in a new direction not preceded by withdrawal 
from the skin, counted until confirmation of spinal canal 
access can be assessed) 
3. Number of passes (any forward movement of the needle, 
calculated as the sum of insertions and redirections) 
4. Incidence of first-pass success (a case that does not 
require reinsertions or redirections) 
5. Subject discomfort during landmarking on a 100mm VAS 
scale 
6. Provider confidence with the identified insertion site on a 
1-5 Likert scale 
7. Procedure success as confirmed by the following 
procedure-specific methods: 
• Epidural anesthesia: able to achieve a T10 or 
greater bilateral sensory level change to cold 
• Spinal anesthesia: able to achieve sensory 
blockade to surgical stimulus at level desired 
• Diagnostic and therapeutic LP: return of CSF 
• Blood patch: able to inject homologous blood into 
epidural space (entry confirmed by loss-of-
resistance) 
Tertiary Endpoints: 
1. Localization time (time from first touch of draped patient 
to identification of an insertion site; for VerTouch, this is 
the time from device placement to movement of the 
applicator to the identified insertion site) 
2. Insertion time (time from retrieval of marker or local 
anesthetic assembly until no further needle advancements 
are made) 
3. Number of bone contacts 
4. Incidence of referral to radiology 
Safety Endpoints 
1. Incidence of post-dural puncture headache (PDPH) 
2. Incidence of unintended dural puncture (specific to 
epidural anesthesia) 
3. Incidence of paresthesia during needle insertion (specific 
to neuraxial anesthesia) 
4. Incidence of traumatic tap (results in visible blood 

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aspiration) 
Exploratory Endpoints: 
1. Procedure time (from positioning of the patient to removal 
of the drape from the subject’s back) 
2. Incidence of conversion from spinal to epidural (specific 
to neuraxial anesthesia) 
Statistical 
Methods 
The primary endpoint will be analyzed using a bootstrap approach 
for the null hypothesis that VerTouch requires more insertions 
than palpation. A one-sided 0.025 p-value will be considered as 
the cut-off for statistical significance. 
 
 
 
 

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Abbreviations 
2D 
 
2-Dimensional 
AE 
 
Adverse Event 
BMI 
 
Body Mass Index 
CI 
 
Confidence Interval 
CFR 
 
Code of Federal Regulations 
CRNA  
Certified Registered Nurse Anesthetist 
CV 
 
Curriculum Vitae 
eCRF  
Case Report Form 
EM 
 
Emergency Medicine 
ESI 
 
Epidural Steroid Injection 
FDA  
Food and Drug Administration 
GCP 
 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
ICH 
 
International Conference on Harmonization 
IFU 
 
Instructions for Use 
IRB 
 
Institutional Review Board 
ITT 
 
Intent to Treat 
LA 
 
Local Anesthetic 
LP 
 
Lumbar Puncture 
NP 
 
Nurse Practitioner 
NSR 
 
Non-Significant Risk 
OTC  
Over the Counter 
PA 
 
Physician’s Assistant 
PDPH  
Post-Dural Puncture Headache 
PM 
 
Pain Medicine 
PHI 
 
Protected Health Information 
PP 
 
Per Protocol 
SAE 
 
Serious Adverse Event 
SAP 
 
Statistical Analysis Plan 
SD 
 
Standard Deviation 
UADE  
Unanticipated Adverse Device Effect  
US 
 
United States 
VAS  
Visual Analog Scale 
 
 
 

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1 
Study Contact Information 
1.1 
Sponsor Contact Information 
IntuiTap Medical, Inc. 
Jessica Traver 
2450 Holcombe Blvd, Suite J 
Houston, TX  77021 
Phone: 626-222-2202 
jtraver@intuitapmedical.com 
1.2 
Key Study Personnel 
1.2.1 Clinical Coordinator 
ICON Clinical Research LLC 
2100 Pennbrook Parkway 
North Wales, PA 19454 
1.2.2 Clinical Study Monitor 
ICON Clinical Research LLC 
2100 Pennbrook Parkway 
North Wales, PA 19454 
1.2.3 Medical Monitor 
ICON Clinical Research 
888-723-9952 (Telephone) 
1.2.4 Statistician 
Stat One, LLC 
2880 Slater Road, Suite 105 
Morrisville, NC 27560 
2 
Introduction / Background and Rationale 
2.1 
Background 
Neuraxial procedures, in which a needle is inserted into the spinal canal through a 
gap in the vertebrae, are performed at a rate of nearly 13 million per year in the US, 
across a myriad of diagnostic and therapeutic clinical scenarios. Among these are 
the 800,000 lumbar punctures (LPs) conducted to diagnose subarachnoid 

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hemorrhage or neurological infection, or to treat neurological diseases[1]. There are 
also 3.1 million deliveries of neuraxial anesthesia to reduce pain during obstetric 
and orthopedic procedures, such as labor/induction, hysterectomy, and total 
hip/knee replacement[2,3]. Additionally, there are 9 million epidural steroid 
injections (ESIs) for back and leg pain relief[4]. Finally, there are epidural blood 
patch procedures, in which autologous blood is used to close holes in the dura 
mater and relieve post-dural puncture headache (PDPH). 
The standard of care involves manual palpation of the patient’s back to detect the 
spinous processes (SPs) and estimate the location of the interspinous needle 
insertion site[5,6]. While providers are trained to perform these procedures with 
meticulous precision and attention to detail, this technique remains highly 
inaccurate, often requiring multiple insertion attempts to properly place the 
needle[7,8]. These attempts lead to patient pain and complications, such as traumatic 
taps and PDPHs; unpredictable procedure times; and poor facility throughput[9,10]. 
The challenge is only exacerbated in patients with high body mass index (BMI), a 
factor that already accounts for 13.8% of procedure failures, and is only worsening 
in the US[11,12]. 
Challenging cases are often referred to radiology for fluoroscopic guidance, at rates 
greater than 47% in settings such as emergency medicine (EM)[13]. However, 
fluoroscopy exposes patients and providers to unnecessary radiation, can rarely be 
used in perioperative settings, and is associated with high costs for overhead, 
patient transport, and assembly of a radiology team[14-16]. Ultrasound may also be 
used to help visualize the vertebrae in challenging cases[17]. However, the modality 
requires significant training on how to interpret its output, and is cumbersome, 
requiring a gel medium and manipulation of a needle in combination with an 
unstable probe. 
VerTouch™ is a novel device that holds promise to reduce the ambiguity 
associated with the palpation technique, and to overcome the shortcomings of other 
imaging-based solutions. VerTouch employs scanning-based tactile imaging to 
detect spinal landmarks, analogous to those sensed during palpation[18]. When 
pressed against the subject’s lower back, the Device’s imaging component detects 
the differences in hardness surrounding the spinous processes. In real-time, data 
collected by the device are processed and visualized as the TactoMap™, a 2D 
pressure map on a full-color display, from which the operator can accurately and 
intuitively identify a suitable insertion site. VerTouch can be used to mark the 
identified site with a supplied surgical marker, or to inject local anesthetic and 
place an introducer or spinal needle to a safe depth at that site. The Device is then 
removed, and the procedure is completed in the standard manner. 

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VerTouch has the potential to require minimal training, cause no additional 
discomfort to the patient, and be seamlessly integrated into any neuraxial 
procedure. By providing the information needed to reveal the underlying lumbar 
anatomy, VerTouch has the potential to help the provider identify an accurate 
insertion site, and have a greater likelihood of success on the first insertion attempt. 
With the potential to reduce the number of needed insertions, VerTouch may 
reduce the frustration, pain, and complications associated with these procedures, 
and standardize the time associated with both the localization and insertion steps. 
Combined, these potential benefits may translate into lower associated costs of care 
for factors like bed and boarding time, as well as readmissions and/or further 
treatment[19-21]. 
2.2 
Rationale 
This study is intended to evaluate the use of VerTouch to reduce the number of 
insertion attempts compared to the conventional manual palpation technique. 
3 
Device Description 
VerTouch is a handheld device, which is capable of assembly and use by a single 
operator, and requires no connection with peripheral systems or software during clinical 
use[22,23]. VerTouch includes reusable and disposable parts (Figure 1).  
 
Figure 1.  Exploded, oblique view of VerTouch subsystems, including the disposable 
Base and Sleeve, and reusable Monitor. In this figure, ‘needle guide’ broadly references 
all needle and marker guidance elements, including the Restrictor. 

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Not shown are the reusable Charging Station, Power Adapter, and PC Connector, none of 
which are directly used for clinical operation; as well as the Disposable Packaging, which 
includes a dedicated mini surgical Marker, and a Dock to facilitate sterile assembly of 
VerTouch components. 
The reusable Monitor is the subsystem that performs image acquisition, processing, and 
display of the TactoMap. It comprises a rechargeable battery, and is sold with a charging 
station to support repeated use. The disposables include a device Base and a Sleeve, both 
of which are single use, and provided terminally sterilized via ethylene oxide (EtO). The 
Base allows for placement of the device against the back, and includes the interactive 
components for scanning-based imaging and needle or marker guidance; while the Sleeve 
prevents contamination from the Monitor during use. Further description on these 
components can be found below; please see the Instructions for Use (IFU)[24] for more 
detail and illustrations. 
3.1 
Assembly 
The sterile disposable components, including the Base, the Sleeve, and a dedicated 
surgical Marker are supplied in a two-part tray. The Tray is wrapped in a Drape, 
which is used to create a sterile field for the device. The wrapped Tray comes in a 
sealed Pouch, along with a disposable Dock, which is used to permit sterile 
electromechanical assembly between the disposable Base and reusable Monitor. 
The Device powers on upon assembly, after which the sleeve can be slid over the 
Monitor, forming the protective barrier.  
3.2 
Workflow Selection 
VerTouch can be used to support needle insertion via any of three workflows: 
marking, placement of a 20-22G, 3.5” or 5” needle, or placement of an introducer. 
With the marking workflow, the device is used to mark an identified insertion site, 
but local anesthetic (LA) injection and needle insertion occur after device removal. 
With the introducer and needle placement workflows, LA is injected, and the 
needle or introducer is placed to a safe depth, through a depth-limiting mechanism 
(Restrictor) integrated into the device (Figure 2; see Section 9.2.1 for further 
description).  
The remainder of the insertion is then completed after Device removal, which is 
enabled by a Needle Release Gate (Gate). Prior to beginning the procedure, the user 
selects their target workflow. If pursuing a marking workflow, the Needle Guide 
can be removed by pulling up the Removal Tab, which reveals the larger-diameter 
Marker Guide, and replaced later, if needed. 

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Figure 2.  Oblique view of Needle Guide, with Restrictor in 5”-needle position. 
3.3 
Device Placement 
With VerTouch, users continue to use standard landmarking techniques to identify 
a safe level for the procedure area. This is typically done by palpating for the tips of 
the iliac crest, which approximately align with the L4-5 interspinous space. This is 
performed prior to draping the patient, such that the procedure area is exposed and 
used to guide Device placement. After Device assembly, the user then grips the 
Handle on the Base with his/her left hand, and places the assembled Device against 
the patient’s back. Midline indicators on the Device can be used to support 
alignment with the midline of the spine. A rubber Bottom Pad on the Base prevents 
slippage of the Device along the back during use. 
3.4 
Imaging 
The Applicator is the primary component that facilitates scanning-based tactile 
imaging. A calibrated, piezoresistive sensor array (Sensor) is mounted to the 
patient-contacting surface of the Applicator, which is designed to optimize feature 
resolution with minimal application of force (Figure 3). 
 
Figure 3.  Bottom view of assembled VerTouch, highlighting sensor mounting. 

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The Applicator is assembled with a Carriage mechanism that is mounted to a fixed 
Track the length of at least two SPs in the indicated patients. Via an Applicator 
Button accessible by the user’s right hand, the Applicator can be slid along the 
craniocaudal (y) axis via the Track; and can be pressed along the anteroposterior 
axis (z), via a spring mechanism that facilitates 2 cm of tissue penetration. A 
flexible printed circuit board assembly (PCBA) connects the Sensor to downstream 
electronics and allows for free y- and z-axis movement; an elastomeric (y-lock) 
strip ensures that the Applicator cannot slide while being pressed. When the user 
presses the Applicator at a first location, a linear positioning system is used to 
display the corresponding 2D pressure data at that location within the imaging 
range on the screen. The user then slides the Applicator to a new location, and 
repeats the process until the imaging range is complete. A Force Gauge on the 
screen (not included in Figure 3) indicates the approximate force of each press to 
help the user apply the same force across presses. Throughout the imaging process, 
the user observes the outputted pressure data with the goal of identifying a blue 
region along the midline corresponding to an interspinous space. Navigation 
Buttons on the left side of the Monitor (not visible in Figure 3) can be used to 
adjust screen brightness and/or scanning sensitivity during imaging. In the event of 
any misalignment and/or the lack of an interspinous space, the image can be reset 
via an operator-facing Reset Button on the Monitor, and scanning can be performed 
at a new location. 
3.5 
Insertion 
The Needle Guide is reversibly attached to the top (cranial side) of the Applicator, 
and its location is presented as a crosshair overlay in the imaging screen. Once an 
insertion site is identified, the user slides the Applicator until the crosshair aligns 
with that site. If a marking workflow has been selected, the user places the Marker 
directly through the exposed Marker Guide. He/she then removes the Device, and 
injects LA and inserts his/her preferred needle on the mark. For the placement 
workflows, LA is first injected directly through the Needle Guide. For introducer 
placement, the user then places the introducer through the Needle Guide. The Gate 
is then opened, which allows the Device to be removed from the partially placed 
introducer. Following Device removal, the introducer is fully inserted and the 
preferred spinal needle is placed through it. The same is done for needle placement; 
however, to ensure the needle does not exceed a safe depth while the device is in 
place, the earlier-described Restrictor is used. The Restrictor is pushed over to align 
with the Needle Guide for placement of a 3.5” needle; and it is further pulled up for 
placement of a 5” needle (Figure 4). Locking mechanisms ensure the Restrictor 
locks in both positions.  

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Figure 4.  Side view (cranial) of VerTouch Needle Guide, depicting Restrictor 
configurations for safe placement of an introducer, and 3.5” and 5” needle, 
extracted from the IFU[24]. 
After needle placement, the Gate is opened to allow the device to be pulled away 
from the introducer or needle. This accomplished by sliding the Device downward, 
craniocaudally; and then leftward, mediolaterally (as viewed against the patient’s 
back). 
With any workflow, the ability of the system to assist with accurate insertion-site 
identification has the potential to be associated with a reduction in insertion 
attempts, although some redirections may still be necessary considering the fixed, 
perpendicular orientation of the Needle Guide. All Needle and Marker Guide 
interactions are performed with the right hand, per standard needle insertion 
training, regardless of handedness. 
3.6 
Disassembly 
Upon needle access to the spinal canal, the user completes his/her procedure per 
standard protocol. Following the procedure, the Sleeve and Monitor are 
disconnected from the Base. The Monitor is dropped into the dock, while the 
remaining components are disposed of with other disposable procedure 
components. 
3.7 
Monitor Maintenance 
After each use, the Monitor is cleaned for visible contaminants. It is then brought to 
a storage location and placed on the VerTouch Charging Station. The Power 
Adapter is used to connect the Charging Station to an outlet for Monitor 
recharging. Note that the Device cannot be used while charging, as the Base and 
Charging Station connect to the same connection port on the Monitor. 
For study use, the Charging Station also has a data transfer port that allows for 
connection to a PC for transfer of study data that can be referenced when 

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investigating anomalous findings and/or can be used to establish a database of 
human TactoMaps for future development. For a given subject, firmware in the 
Monitor captures pressure data corresponding to the final scan that was used to 
identify an insertion site. Sampled at a rate of at least 10Hz, these include Sensor 
readings before and after integration into the full scanning range (referred to as 
push images and built images, respectively). Also included is header information 
for each sample, including the current timestamp, sensitivity value, linear position 
value, and force level. To provide additional information, users can flag the frame 
at which the Applicator was moved to align the Needle Guide with their identified 
site by pressing and holding the central Navigation Button on the Monitor. Data 
transfer software is loaded onto on-site study PCs, which allows for upload of these 
data from the Monitor following each procedure. 
3.8 
Maintenance Mode 
VerTouch also has a touchscreen-enabled maintenance mode, which can be 
operated by a non-clinical user to adjust time and date settings, and/or to perform 
password-protected firmware updates. 
3.9 
User and Subject Characteristics 
Patients undergoing neuraxial procedures have varying characteristics, though most 
receiving neuraxial anesthesia for obstetric procedures are pregnant. Indicated 
patients have a BMI of ≤42kg/m2 and may be in the seated or lateral decubitus 
position. 
The Device is intended for use by all providers credentialed to perform these 
procedures. Table 1 summarizes some such providers, as well as procedure-specific 
information, such as the VerTouch workflow(s) applicable to each procedure.  
Table 1.  Intended Users and Procedures 
Name 
Applicable Workflow(s) 
Settings 
Locations 
Providers 
Diagnostic 
LP 
Needle placement, 
marking 
EM 
Emergency Room 
EM Physician, PA 
NE 
Neurology Suite 
Neurologist, Neurosurgeon, PA 
Therapeutic 
LP 
Needle placement, 
marking 
NE 
Neurology Suite 
Neurologist, Neurosurgeon, PA 
Neuraxial 
Anesthesia 
Marking, introducer 
placement 
AN 
Operating Room 
Anesthesiologist, CRNA 
Blood 
Patch 
Marking 
AN 
Operating Room 
Anesthesiologist, CRNA 
ESI 
Marking 
PM 
PM Suite 
PM Physician, PA, CRNA 
AN 
Operating Room 
Anesthesiologist, PA, CRNA 
PA = physician assistant; CRNA = certified registered nurse anesthetist; NE = neurology, AN = 
anesthesiology (includes obstetric and orthopedic); PM = pain medicine 

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Note that users may have either handedness, and be seated or standing during use. 
MDs may include residents (a type of clinical trainee), fellows, and attendings. Not 
listed below are nurse practitioners (NPs), who are credentialed to perform 
neuraxial procedures in some facilities. In some states, anesthesiology assistants 
(AAs) may also perform these procedures in the anesthesiology setting. 
3.10 Intended Use 
VerTouch has not yet been cleared by FDA, and is intended to aid in the 
localization of an interspinous space, and the placement of a needle at the identified 
site, for diagnostic and therapeutic spinal punctures, including LPs, neuraxial 
anesthesia (spinals, epidurals, and combined spinal-epidurals), ESIs, and epidural 
blood patches. The device includes functionality to guide a marking tool or needle. 
All investigational devices will have the following label statement:  CAUTION – 
Investigational Device. Limited by Federal (or United States) Law to 
Investigational Use. 
4 
Device Accountability 
4.1 
Device Receipt 
IntuiTap Medical will ship devices directly to the clinical sites, to the attention of 
the Investigator or designee at that site. Device receipt and inventory procedures 
will be determined by the individual sites’ standard operating procedures. At a 
minimum, a device inventory log will record device serial numbers for reusables 
and disposables, date of receipt, and disposition. At least two sets of reusable 
VerTouch components will be provided to each clinical setting within each site. 
4.2 
Device Storage 
Devices will be stored in secured rooms under ambient conditions, which meet 
VerTouch storage requirements. Reusable monitors will be stored on VerTouch 
charging stations as described earlier; disposables will be stored in their sterile 
packaging. Device access will be controlled by the Site Investigator or designee. 
4.3 
Device Dispensing 
For each procedure, disposable units will be dispensed for use by the Site 
Investigator as per the allocation scheme; paired with one of the reusable monitors 
available within the clinical setting. Device serial numbers will be recorded on the 
subject’s case report form. Device records will be reconciled at each monitoring 

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visit. This reconciliation will be logged on the device accountability form, and 
signed and dated by the designated study team member. 
4.4 
Device Disposition 
At the conclusion of the study, all reusable study components, including monitors, 
charging stations, power adapters, and PC connectors are to be returned to the 
Sponsor. Consumable components will be recorded and disposed of in accordance 
with local medical waste regulations. Device return will be recorded and reconciled 
with device assignment and accountability records. 
4.5 
Return or Destruction of Unused Devices 
Following a full product reconciliation, all unused devices are to be returned to 
IntuiTap Medical at the address listed below. 
IntuiTap Medical, Inc. 
965 W Chicago Ave. 
Chicago, IL 60642 
5 
Study Objectives 
The primary objective of this study is to establish the superiority of VerTouch versus the 
conventional palpation technique for the number of needle insertion attempts required in 
diagnostic and therapeutic neuraxial procedures. 
6 
Study Design 
6.1 
Overview of Study Design 
After Informed Consent is obtained, subjects will be randomized 1:1 into two 
groups via the block randomization method with a list held in each test setting. 
Standard landmarking techniques will be used in both groups to identify the 
procedure area. For subjects randomized to the tactile-imaging group (T), 
VerTouch will be used to identify an interspinous space and to place a marker, 
introducer, or needle. For subjects randomized to the palpation group (P), the 
palpation-landmarking method will be used. After marker, introducer, or needle 
placement, the procedure will continue in the usual manner for subjects in both 
groups (Figure 6).  
A designated study observer within each setting will record the time to identify an 
insertion site; time to place the marker, introducer, or needle; number of insertions, 
re-directions, and bone contacts (counted until confirmation of spinal canal access 

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can be assessed); incidence of procedure success; subject’s level of discomfort 
during landmarking; and provider’s level of confidence with the identified insertion 
site. Total procedure time, incidence of traumatic taps, and incidence of referrals to 
radiology or pain management will be recorded in all settings. In anesthesiology, 
incidences of paresthesia, unintended dural puncture, and conversion from spinal to 
epidural anesthesia, will be collected for exploratory analysis, where applicable. 
Any usability issues or device malfunctions observed during the clinical study will 
also be documented. 
Informed Consent 
Subject Screening
Demographics and 
Baseline Data 
Collection
Randomization
Providers:
MD
PA
CRNA
NP
Palpation
Tactile Imaging
Access Spinal Canal
 
Figure 5.  Overall Study Design 
Although spinal punctures in all clinical settings involve the same localization and 
insertion processes, there may be variations in setting, subject, and/or provider 
characteristics. While early VerTouch testing has not evidenced any corresponding 
variations in device usability and/or outcomes associated with these variations, the 
study is designed to capture them. 
Accordingly, EM, neurology, and anesthesiology settings will be approximately 
evenly represented in the study, with at least 24 subjects enrolled in each. To 
adequately represent patients undergoing obstetric and orthopedic procedures, 
enrolled anesthesiology subjects will be approximately evenly split between these 
sub-settings. The PM setting will not be included in the study, as there are 
limitations, particularly with respect to reimbursement, for ESIs performed with 
palpation or other non-fluoroscopic techniques. However, PM providers will be 
represented in IntuiTap’s summative usability study, and undergo the same 

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anesthesiology training as those clinical study investigators specialized in obstetrics 
and orthopedics. 
Additionally, investigators will form a representative sample of typical neuraxial 
procedure providers, including MDs (residents, fellows, and attendings), PAs, and 
CRNAs, where applicable. Residents must be in their second post-graduate year 
and above, having performed at least 5 neuraxial procedures in the past 12 months, 
and are considered trainees. Apart from their level of training, investigators should 
have a representative range of relevant experience, indicated by the approximate 
number of neuraxial procedures they have performed in the past year. To ensure 
adequate user variability, a single investigator should perform no more than 20% of 
procedures in his/her setting (corresponding to a minimum of approximately 6 
procedures per investigator). Any provider type not included in the study will have 
been assessed in formative and/or summative human factors testing. 
6.2 
Anticipated Duration of the Clinical Investigation 
Study duration is anticipated to be approximately 4 months. 
6.3 
Evaluation Criteria / Effectiveness and Safety 
6.3.1 Primary Clinical Endpoint 
The number of insertion attempts (any forward movement of the needle 
following puncture of the skin) in the study device group as compared to the 
control group (palpation). Attempts are counted until confirmation of spinal 
canal access can be assessed. 
6.3.2 Secondary Clinical Endpoint(s) 
1. Incidence of first-insertion success (a case that does not require any 
reinsertions, but can include any number of redirections) 
2. Number of redirections (any forward movement of the needle in a 
new direction not preceded by withdrawal from the skin, counted 
until confirmation of spinal canal access can be assessed) 
3. Number of passes (any forward movement of the needle, calculated 
as the sum of insertions and redirections) 
4. Incidence of first-pass success (a case that does not require 
reinsertions or redirections) 
5. Subject discomfort during landmarking on a 100mm VAS (See 
Section 17.1)  

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6. Provider confidence with the identified insertion site on a 1-5 Likert 
scale (See Section 17.2) 
7. Procedure success as confirmed by the following procedure-specific 
methods: 
• Epidural anesthesia: able to achieve a T10 or greater bilateral 
sensory level change to cold 
• Spinal anesthesia: able to achieve sensory blockade to surgical 
stimulus at level desired 
• Diagnostic and therapeutic LP: return of CSF 
• Blood patch: able to inject homologous blood into epidural 
space (entry confirmed by loss-of-resistance) 
6.3.3 Tertiary Endpoints 
1. Localization time (time from first touch of draped patient to 
identification of an insertion site; for VerTouch, this is the time 
from device placement to movement of the applicator to the 
identified insertion site) 
2. Insertion time (time from retrieval of marker or LA assembly until 
no further needle advancements are made) 
3. Number of bone contacts (counted until confirmation of spinal 
canal access can be assessed) 
4. Incidence of referral to radiology 
6.3.4 Safety Endpoints 
1. Incidence of post-dural puncture headache (PDPH) 
2. Incidence of unintended dural puncture (specific to epidural 
anesthesia) 
3. Incidence of paresthesia during needle insertion (specific to 
neuraxial anesthesia) 
4. Incidence of traumatic tap (results in visible blood aspiration) 
6.3.5 Exploratory Endpoints 
1. Procedure time (from positioning of the patient to removal of the 
drape from the subject’s back)  
2. Incidence of conversion from spinal to epidural (specific to neuraxial 
anesthesia) 

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6.4 
Study Population 
Subjects admitted to EM, neurology, or anesthesiology settings that require a 
neuraxial procedure as part of their management or work up, and that meet 
inclusion and exclusion criteria will be approached by research staff for enrollment 
in the study. Spinal punctures in these clinical settings involve the same 
localization and insertion processes, through access to the spinal canal. Written 
informed consent will be obtained in person by the study coordinator or designee.  
6.4.1 Sample Size 
It is expected that approximately 120 subjects will be screened to meet a 
target enrollment goal of 96 subjects (48 in each group) across 3 
investigational sites. 
The superiority hypothesis for the number of insertion attempts with IntuiTap 
(µ1) and palpation (µ2) is: 
H0: µ1 ≥ µ2  vs  H1: µ1 < µ2  
The sample size was selected based on historical information and previous 
clinical trial data collected with the VerTouch device. A literature survey 
identified eight (8) papers where the mean and standard deviation (SD) for 
insertions for palpation were identified[25-32]. The definitions appear similar to 
the proposed endpoint. The mean attempts ranged from 1.3 to 3.3 and SD 
ranged from 0.0 to 6.9. A weighted average of the means and standard 
deviations provided an average of mean of 2.3 and SD of 2.8[33]. Based on the 
spread of individual results, a mean of 2.1 and SD of 1.5 was considered a 
reference for the power analysis. 
A sample of 81 attempts was available for the VerTouch device across 
several iterations of the device. Of the attempts, 90% were successes on the 
first attempt and the mean number of attempts was 1.1 and SD was 0.6. 
In order to assess the sample size, given the truncated nature of the 
distribution and the planned use of a bootstrap analysis, a simulation study 
was performed. Random vectors were built by taking the ceiling of absolute 
values of a mixture for two normal distributions to build long-tailed 
distributions with means and standard deviations similar to those above. 
Analyses were done using a bootstrap analysis of the difference in means, 
Wilcoxon Test, T-test with unequal means, and a T-test of log-transformed 
data. For a sample size of 24 subjects per group, the bootstrap analysis, 

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Wilcoxon Test, and T-test of log-transformed data had at least 92% power 
while a T-test of the observed counts had 89% power.   
In addition, an estimate of the secondary endpoint of first attempt success of 
approximately 50% was obtained in the simulation exercise for palpation. 
The planned sample size of 48 per group provides 90% power when 
compared to a first attempt success rate of 81% in the VerTouch group. 
Hence, the study is also expected to have adequate power for the primary 
analysis and the secondary endpoint of success on the first insertion. 
6.4.2 Subject Recruitment 
Subjects will be recruited from investigators practicing at large hospital 
settings from Anesthesiology, Neurology or the Emergency Departments. 
Those departments will be used to recruit subjects into this study. 
6.4.3 Subject Screening 
Following Informed Consent, subjects will be screened for eligibility. Height 
and weight will be recorded, and BMI calculated. Scheduled date of eligible 
procedure will be recorded. Relevant medical history and age will be 
assessed for concordance with inclusion and exclusion criteria. Subjects who 
do not meet eligibility criteria will be recorded as Screen Failures. At subject 
screening, subjects will be given a subject ID number that encodes both 
investigational site and subject number. 
6.4.4 Prior and Concomitant Medications 
There are no restrictions on prior or concomitant medications. However, 
concomitant prescription and over the counter (OTC) pain and anti-anxiety 
medications must be recorded in the source documentation and in the eCRF. 
6.4.5 Inclusion Criteria 
Subjects will be eligible to participate in the study if all of the following 
conditions exist: 
1. Males and females aged 18 years and above, inclusive 
2. Subjects scheduled for one of the following procedures: 
• Diagnostic LP (collection of CSF and/or measurement of 
ICP to diagnose hemorrhage or neurological infection) 
• Therapeutic LP (intrathecal injection of therapeutic agents; 
drainage of CSF to treat pseudotumor cerebri) 

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• Planned orthopedic or obstetric procedure, such as 
labor/induction, cesarean section, hysterectomy, or total 
hip/knee replacement, with neuraxial anesthesia (injection 
of anesthetic into spinal and/or epidural space to reduce 
pain during procedure)  
• Epidural blood patch (use of autologous blood to close 
holes in the dura mater and relieve PDPH) 
3. Subjects having a BMI ≤42kg/m2 
6.4.6 Exclusion Criteria 
Subjects will be excluded from participation in the study if any of the 
following conditions exist:  
1. Patient does not provide informed consent 
2. Skin or soft tissue infection near the puncture site 
3. Allergy to local anesthetic 
4. Uncorrected coagulopathy 
5. Acute spinal cord trauma 
6. History of lumbar spinal surgery 
7. Prior known failed neuraxial anesthesia 
8. Diagnosed 
scoliosis, 
thoracic 
kyphosis, 
lumbar 
lordosis, 
scleroderma, ankylosing spondylitis, or lumbar spinal stenosis 
9. Incarcerated subjects 
6.4.7 Exit / Discontinuation Criteria 
Subjects will exit the study if any of the following conditions exist: 
1. 
Subject voluntarily withdraws from the study. 
2. 
Subject death. 
3. 
Subject acquires any of the listed exclusion criteria. 
4. 
Subject completes the protocol. 
5. 
Subject’s well-being, in the opinion of the Investigator, would be 
compromised by study continuation. 
7 
Study Procedures 
7.1 
Informed Consent 
All prospective subjects for this study will be provided a consent form describing 
this study and providing sufficient information for subjects to make an informed 
decision about their participation in this study. The consent form will be submitted 

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with the protocol for review and approval by the IRB for the study. The formal 
consent of a subject, using the IRB-approved consent form, must be obtained 
before that subject is submitted to any study procedure. This consent form must be 
signed by the subject or legally acceptable surrogate, and the investigator-
designated research professional obtaining the consent. A blank copy of the IRB-
approved form must be kept on-site and by the Investigator. 
Subjects who sign an informed consent will be considered enrolled in this study. 
Subjects who provide consent for participation but do not meet all study eligibility 
criteria will be considered screen failures. 
7.2 
Vulnerable Populations 
As noted above adolescent subjects (18-21 years) will be eligible for participation 
in this study. Pregnant women will be recruited for the cohort including obstetric 
procedures, such as labor/induction and cesarean section, and eligible to participate 
in other cohorts as well.  
Other recognized vulnerable populations will not be targeted for recruitment, 
however individual subjects within vulnerable populations may be enrolled. The 
Human Subject’s Protections procedures employed in this protocol are sufficient to 
protect the rights and welfare of any subject within an eligible vulnerable 
population and no additional measures are necessary. 
7.3 
Randomization Scheme 
Qualifying subjects will be randomized 1:1 via a block randomization scheme to 
either the tactile-imaging group (T) or the palpation group (P) within each setting 
(e.g. EM, neurology, or anesthesiology). 
7.4 
Clinical Procedures 
7.4.1 Visit 1 
Screening  
At the screening visit the following activities and information will be 
collected: 
• Informed Consent 
• Physical Examination (height/weight) 
• Eligibility Determination 
• Randomization and Subject ID Assignment 

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• Demographics (gender, age, race, ethnicity) 
• Relevant Medical History 
• Concomitant Medications 
At Treatment 
At the time of treatment, the following activities and information will be 
collected: 
 
• Concomitant Medications 
• Pain and/or anti-anxiety medication(s) given for the procedure  
• Provider level of training (e.g. resident, fellow, attending, PA, CRNA, 
NP) 
• Provider number of years of in practice 
• Provider experience (i.e. number of neuraxial procedures performed 
in the past 12 months) 
• Provider 
specialty 
(i.e. 
emergency 
medicine, 
neurology, 
anesthesiology) 
• Procedure setting (i.e. emergency medicine, neurology, orthopedic 
anesthesiology, obstetric anesthesiology) 
• Type of neuraxial procedure (i.e. diagnostic LP, therapeutic LP, spinal 
anesthesia, epidural anesthesia, CSE, blood patch) 
• Reason for Neuraxial Procedure (if not diagnostic LP or blood patch), 
such as: 
o Therapeutic LP: CSF drainage, intrathecal injection, other 
o Orthopedic procedure: total hip replacement, total knee 
replacement, other 
o Obstetric 
procedure: 
labor/induction, 
cesarean 
section, 
hysterectomy, tubal ligation, other  
The subject will be treated with the device or control, per Figure 6 below (see 
IFU for more detailed VerTouch steps)[24]. Initial landmarking for vertebral 
level is performed by standard technique in both groups in order to identify a 
safe level when placing the drape to expose the procedure area. 
Listed data will be recorded in source documentation, by a member of the 
study team designated as an observer, as they become available. The observer 
will also be responsible for counting needle insertions and redirections. Note 
that procedure success may be reported at different points within the 
treatment, depending on when spinal access can be confirmed for the 
particular neuraxial procedure. 

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Figure 6.  Flowchart of Visit 1 treatment. 
Post-Treatment 
After the completion of the procedure, the following activities and 
information will be collected: 
• Patient position (seated, lateral decubitus) 

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• Length, gauge, bevel (cutting, non-cutting), and type (straight, 
curved) of needle used  
• VerTouch workflow followed (N/A (control group), marking, 
introducer placement, needle placement) 
• Calculation of number of re-insertions (1 less than insertions) 
• Incidence of first-insertion success (1 insertion, any number of 
redirections) 
• Calculation of number of passes (sum of insertions and redirections) 
• Incidence of first-pass success (1 pass) 
• Calculation of localization, insertion, and procedure times (based on 
start and end times) 
• Incidence of traumatic tap 
• Incidence of referral to radiology 
• Incidence of conversion from spinal to epidural (neuraxial anesthesia 
only) 
• Incidence of paresthesia (neuraxial anesthesia only) 
• Incidence of PDPH 
• Intensity of PDPH (mild, moderate, severe) 
• Incidence of unintended dural puncture (epidural anesthesia only) 
• Subject Discomfort Assessment 
• Provider Confidence Assessment 
• Adverse Event Assessment 
• Upload of data from VerTouch 
Post-procedure, the subject will be monitored for adverse events, adverse 
device effects or other reportable observations to ensure safety, entering 
relevant data into the eCRF. At the conclusion of the visit, the subject will be 
released and considered complete. After each procedure, imaging data from 
VerTouch will be uploaded by the designated observer to a study portal to 
support investigation of any anomalous finds and/or establishment of a 
human image database.  
7.4.2 Visit 2 
Visit 2 must occur at 3 ± 2 days following Visit 1. Phone, or other 
appropriate follow-ups will be made at Visit 2 to assess the presence and 
intensity of PDPH in subjects, and assess potential adverse events. At the 
conclusion of Visit 2, a Subject Study Exit CRF will be completed. 

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7.5 
Follow-Up Procedures and Therapy Transitions 
Adverse events identified in the study will be followed to resolution. No additional 
follow-up procedures or therapy transitions are required. 
7.6 
Study Timetable / Schedule of Events 
Table 2.  Schedule of Events 
Assessment 
Visit 1 
Visit 2 
Screening 
Treatment 
Post-Treatment 
Follow-up 
Demographics 
X 
 
 
 
Medical History 
X 
 
 
 
Physical Exam (Height & 
Weight) 
X 
 
 
 
Inclusion/Exclusion 
Criteria 
X 
 
 
 
Informed Consent 
X 
 
 
 
Randomization 
X 
 
 
 
Concomitant Medications 
X 
X 
 
Procedure Completion 
 
X 
 
 
Discomfort Assessment 
 
 
X 
 
Provider Satisfaction 
Assessment 
 
 
X 
 
PDPH 
 
 
X 
Adverse Event Assessment 
 
X 
X 
Adverse Device Effect 
Assessment 
 
X 
X 
 
7.7 
Deviations from the Clinical Protocol 
The study will be conducted as described in this protocol. Investigators are not 
permitted to deviate from this protocol except to protect patient rights, safety, or 
well-being. Any deviations from this protocol must be documented by the 
Investigator. A description of the deviation from the protocol and justification must 
be recorded on the Protocol Deviation Form. If an emergency situation arises in 
which the rights, safety or well-being of a subject may require immediate 
alternative intervention, the Investigator should act in the best interest of the 
subject. Sponsor and the site’s IRB must be notified immediately if this occurs. 
This should be followed with written confirmation that describes the emergency 
action and outcomes, to Sponsor and per IRB reporting requirements.  
Protocol deviations will be reviewed during routine monitoring visits. Investigators 
will be required to identify preventive and corrective actions to prevent further 
deviations. An Investigator may be disqualified from the study for repeated and/or 
egregious protocol deviations. 

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7.8 
Subject Withdrawal 
Subject withdrawals are not anticipated due to the short nature of the subject 
participation in the study. If a subject withdraws, a Study Exit CRF will be 
completed.  
7.9 
Subject Compensation 
Subjects will receive no payment or stipend for participation in this study. 
8 
Data Collection and Analysis 
8.1 
Subject Population(s) for Analysis 
The study populations are defined as follows: 
• 
Intent-to-treat population (ITT): Consists of all randomized subjects 
according to their randomized group. 
• 
Per-protocol population (PP): Consists of all subjects who received their 
randomized treatment, did not have an inclusion or exclusion violation, 
had a procedure success, and did not have a major protocol deviation. 
The primary analysis and all study results will be analyzed using the ITT 
population. The primary analysis will be repeated using the PP population. 
8.2 
Statistical Methods 
This section describes the planned statistical analyses for this study. A detailed 
Statistical Analysis Plan (SAP) will be completed and placed on file prior to 
enrollment. The SAP will contain a comprehensive explanation of the methodology 
used in the statistical analyses described below. 
All CRF data will be made available in data listings or in Excel spreadsheets. Data 
listings will be sorted by subject and visit date, or adverse event onset date. All 
statistical analyses will be based on the available data. The study results will be 
reported in summary tables using standard descriptive statistics. Standard numeric 
descriptive statistics include the n (number of non-missing observations), mean, 
median, minimum value, and maximum value. Categorical data will be summarized 
using the counts and percentages based on the non-missing values.  
Statistical analyses will be performed to assess the homogeneity of the study 
populations, evaluate the primary hypothesis, and evaluate the impact of covariates 
on the performance of the VerTouch device. Standard statistical tests used for 

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hypothesis testing are the t-test for numeric measures and the likelihood ratio chi-
square test for categorical variables. For categorical variables with small cell counts 
(less than 5), Fisher’s exact test will be used. For inferential analyses, unless 
otherwise indicated, a two-sided p-value of less than or equal to 0.05 will be 
considered statistically significant. All confidence intervals (CIs) will be two-sided 
95% intervals. Note that p-values reported for tertiary and exploratory endpoints 
will be used for reporting but would not be used in product labeling. 
8.2.1 Adjustments for Multiplicity 
The study has a single primary endpoint needed for the superiority analysis. 
If that analysis reaches statistical significance, then the following additional 
hypothesis of the secondary variables will be considered sequentially such 
that if one analysis is statistically significant, then the next hypothesis can be 
evaluated to control for the Type I error for these analyses: 
Additional Hypothesis 1: The null hypothesis that the binary rate of first-
attempt success is the same in both groups will be analyzed using a likelihood 
ratio test (H0: p1 = p2 vs H1: p1 ≠ p2 where p1 is the success rate in VerTouch 
subjects and p2 is the success rate in control subjects). The results will be 
considered statistically significant if the two-sided p-value is less than 0.05 
and the VerTouch success rate is higher than the control rate). 
Additional Hypothesis 2: The null hypothesis that the mean number of 
redirections is the higher in the VerTouch subjects compared to the control 
group using a T-test with unequal variance assumption (H0: µ1 ≥ µ2 vs H1: µ1 
< µ2 where µ1 is the mean in VerTouch subjects and µ2 is the mean in control 
subjects). The results will be considered statistically significant if the one-
sided p-value is less than 0.025. 
Additional Hypothesis 3: The null hypothesis that the mean number of 
passes is the higher in the VerTouch subjects compared to the control group 
using a T-test with unequal variance assumption (H0: µ1 ≥ µ2 vs H1: µ1 < µ2 
where µ1 is the mean in VerTouch subjects and µ2 is the mean in control 
subjects). The results will be considered statistically significant if the one-
sided p-value is less than 0.025. 
Additional Hypothesis 4: The null hypothesis that the binary rate of first-
pass success is the same in both groups will be analyzed using a likelihood 
ratio test (H0: p1 = p2 vs H1: p1 ≠ p2 where p1 is the success rate in VerTouch 
subjects and p2 is the success rate in control subjects). The results will be 

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considered statistically significant if the two-sided p-value is less than 0.05 
and the VerTouch success rate is higher than the control rate). 
Additional Hypothesis 5: The null hypothesis that the mean subject 
discomfort rated during landmarking from 0 to 10 is higher in the VerTouch 
subjects compared to the control group using a T-test with unequal variance 
assumption (H0: µ1 ≥ µ2 vs H1: µ1 < µ2 where µ1 is the mean in VerTouch 
subjects and µ2 is the mean in control subjects). The results will be 
considered statistically significant if the one-sided p-value is less than 0.025. 
Additional Hypothesis 6: The null hypothesis that the mean provider 
confidence with the identified insertion site rated 1 to 5 is lower in the 
VerTouch subjects compared to the control group using a T-test with unequal 
variance assumption (H0: µ1 ≤ µ2 vs H1: µ1 > µ2 where µ1 is the mean in 
VerTouch subjects and µ2 is the mean in control subjects). The results will be 
considered statistically significant if the one-sided p-value is less than 0.025. 
Additional Hypothesis 7: The null hypothesis that the binary rate of 
procedure success is the same in both groups will be analyzed using a 
likelihood ratio test (H0: p1 = p2 vs H1: p1 ≠ p2 where p1 is the success rate in 
VerTouch subjects and p2 is the success rate in control subjects). The results 
will be considered statistically significant if the two-sided p-value is less than 
0.05 and the VerTouch success rate is higher than the control rate). 
8.2.2 Primary Effectiveness Analysis 
The study is designed to evaluate whether the use of the VerTouch device is 
able to reduce the number of insertion attempts to successfully access the 
spinal canal in a spinal puncture as compared to the conventional palpation 
technique. The primary hypothesis test will be performed by a bootstrap 
analysis resampling the cases in each group. The null hypothesis for the 
analysis is: 
H0: µ1 ≥ µ2  vs  H1: µ1 < µ2 
Where µ1 is the mean attempts in the VerTouch group and µ2 is the mean for 
palpation. 
This hypothesis will be evaluated using a bootstrap analysis with a one-sided 
0.025 test to indicate statistical significance. The results will be presented for 
the difference in means and the associated 95% CI; and the ratio of the 
VerTouch mean divided by the palpation mean and the associated 95% CI. 

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The primary analysis will include the total insertions for each subject 
regardless of success on the final placement attempt.   
The following supporting analyses will be performed: 
• The primary analysis will be performed only for subjects who had a 
procedure success. 
• If there are missing data, best- and worst-case imputation analyses will 
be performed. For the worst-case imputation, the highest observed 
value will be imputed in the VerTouch group and the lowest value in 
the palpation group. The best-case analysis reverses the pattern of 
imputations.  
• A Wilcoxon rank-sum test will be used to evaluate the null hypothesis 
that median attempts are the same in both arms using a two-sided test 
with a p-value less than or equal to 0.05 considered significant. 
• Homogeneity of the log-transformed count results will be assessed 
using an ANOVA with site, treatment, and site-treatment interaction 
terms. A p-value for the site-treatment interaction of less than or equal 
to 0.15 will be considered statistically significant for this analysis. The 
n, mean, and SD of values by study site will be provided by treatment 
group. 
• The observed attempts will be evaluated through a t-test for unequal 
variances comparing the difference in the log (insertion attempts) for 
each group. The difference will be transformed with the exponent 
function to provide the ratio of the geometric mean attempts and a 
two-sided 95% CI for the ratio. 
The following subgroups will be considered in exploratory covariate 
analyses: 
• BMI (kg/m2): underweight (<18.5), normal (18.5-24.9), overweight 
(25-29.9), class 1 obesity (30.0-34.9), class 2-3 obesity (≥35 .0) 
• Age (years): adolescent (<22), young adult (22-40), middle-aged adult 
(41-65), older adult (>65) 
• Provider type: MD, PA, CRNA, AA, NP 
• Provider specialty: emergency medicine, neurology, anesthesiology 
• MD level (MDs only): resident, fellow, attending 
• Provider years in practice: <5, 5-10, >10 
• Provider experience (number of neuraxial procedures in past 12 
months): 5-25, 26-50, 51-100, >100 

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• Neuraxial procedure: diagnostic LP, therapeutic LP, neuraxial 
anesthesia, blood patch 
• Medication given for procedure: none, pain, anti-anxiety 
• Needle type: spinal 20-22G cutting, spinal 20-22G non-cutting, spinal 
>22G, Tuohy, CSE 
• VerTouch workflow (VerTouch subjects only): marking, introducer 
placement, needle placement 
Subgroup levels will only be considered if there are at least 8 subjects within 
the covariate level across both treatments.  
8.2.3 Additional Analyses 
The tertiary and exploratory endpoints will be summarized descriptively. 
Tertiary endpoints of localization time, insertion time, and number of bone 
contacts will also be evaluated for homogeneity of the group results using a 
Mann-Whitney test. The exploratory endpoint of procedure time will also be 
evaluated with a Mann-Whitney test. The tertiary, safety, and exploratory 
incidence endpoints will be evaluated for homogeneity of the rates across the 
treatment groups using likelihood ratio tests. 
8.2.4 Safety Analyses 
Adverse events will be summarized using the number and percentage of 
subjects with one or more events and well as the total count of events. 
Adverse events will be summarized overall, by device relatedness, 
seriousness, and severity. Adverse events will only be summarized 
descriptively. 
9 
Safety and Adverse Events 
9.1 
Definitions 
Adverse Event (AE) 
An adverse event (AE) is any symptom, sign, illness or experience that 
develops or worsens in severity during the course of the study. Intercurrent 
illnesses or injuries will be regarded as adverse events. Abnormal results of 
laboratory or diagnostic procedures are considered to be adverse events if the 
abnormality: 
• Results in study withdrawal 
• Is associated with a serious adverse event 

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• Is associated with clinical signs or symptoms 
• Leads to additional treatment or to further diagnostic tests 
• Is considered by the Investigator to be of clinical significance. 
Serious Adverse Event (SAE) 
A serious adverse event (SAE) is any adverse event that is: 
• Fatal 
• Life-threatening 
• Requires or prolongs a hospital stay 
• Results in persistent or significant disability or incapacity 
• Necessitates medical or surgical intervention to prevent one of 
the outcomes listed above (i.e., to preclude permanent 
impairment of a body function or permanent damage to a body 
structure) 
• A congenital anomaly or birth defect 
Hospitalization 
Hospitalization shall include any initial admission (even if less than 24 hours) 
to a healthcare facility as a result of a precipitating clinical adverse effect; to 
include transfer within the hospital to an intensive care unit. Hospitalization 
or prolongation of hospitalization in the absence of a precipitating, clinical 
adverse effect (e.g., for a preexisting condition not associated with a new 
adverse effect or with a worsening of the preexisting condition; or admission 
for a protocol-specified procedure) is not, in itself, a serious adverse effect. 
Unanticipated Adverse Device Effect (UADE) 
An unanticipated adverse device effect is any serious adverse effect on health 
or safety or any life-threatening problem or death caused by, or associated 
with, a device, if that effect problem, or death was not previously identified 
in nature, severity, or degree of incidence in the investigational plan, or any 
other unanticipated serious problem associated with a device that relates to 
the rights, safety, or welfare of subjects. 
Adverse Event Relationships to the Study Device 
The relationships between adverse events and the study device will be 
characterized by the definitions below. 
• Unrelated: This category applies to those adverse events which, after 
careful consideration, are clearly and incontrovertibly due to extraneous 
causes (disease, environment, etc.) 

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• Possibly Related: This category applies to those adverse events for which, 
after careful medical consideration at the time they are evaluated, a 
connection with the study device administration appears unlikely but 
cannot be ruled out with certainty. An adverse experience may be 
considered possibly related if or when (at least two of the following): 
o It follows a reasonable temporal sequence from administration of 
the study device. 
o It could not readily have been produced by the subject’s clinical 
state, environmental or toxic factors, or other modes of therapy 
administered to the subject. 
o It follows a known pattern of response to the study device. 
• Probably Related: This category applies to those adverse events which, 
after careful medical consideration at the time they are evaluated, are 
believed with a high degree of certainty to be related to the study device. 
An adverse experience may be considered probably related if or when (at 
least three of the following): 
o It follows a reasonable temporal sequence from administration of 
the study device. 
o It could not be reasonably explained by the known characteristics of 
the subject’s clinical state, environmental or toxic factors or other 
modes of therapy administered to the subject. 
o It disappears or decreases on cessation or reduction in device 
exposure. There are important exceptions when an adverse event 
does not disappear upon discontinuation of the device, yet device-
relatedness clearly exists. 
o It follows a known pattern of response to the study device. 
• Definitely Related: An adverse event may be considered definitely related 
if or when all of the following apply: 
o The event is a known effect of the device, or procedure 
o The event follows an obvious sequence of time, from the device’s 
implantation or activation, or procedure, for which the event is 
directly attributed to the administration, implantation, activation, or 
procedure. 
o The event ceases with discontinuation of the device, or procedure 
(and reoccurs on restarting). 
Device Malfunction/Failure – Device Specific Events 
A device specific event (DSE) is any malfunction of the device, related or not 
to the device, resulting or not in the patient undergoing undesirable or 
harmful experience, that occurs in relation with the conduct of the study. 

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Device malfunction means the failure of a device to meet its performance 
specifications or otherwise perform as intended. Performance specifications 
include all claims made in the labeling for the device. The intended 
performance of a device refers to the intended use for which the device is 
labeled or marketed. 
Device malfunction may or may not result in the subject experiencing a 
harmful effect. 
All AEs/SAEs associated with a device failure are by definition device 
related. 
9.2 
Safety Monitoring Plan 
Procedures for ensuring subject safety are addressed throughout this protocol, and a 
separate Data Safety Monitoring Plan will not be required. Any incidental findings 
associated with clinical procedures will be provided to the subject with a 
recommendation for follow-up with their primary physician. The site Principal 
Investigator, or designee, will serve as the Emergency Medical Safety Contact for 
subjects enrolled at that site.  
9.2.1 Anticipated Risks / Risk Mitigation 
As discussed, neuraxial procedures have long been associated with concerns 
of uncertainty and subjectivity. VerTouch is designed to integrate into the 
existing clinical workflow and environment; and to offer additional 
information in support of these procedures, with greater objectiveness than 
palpation, and greater interpretability than ultrasound. 
IntuiTap has performed risk analyses in accordance with ISO 14971:2019, 
IEC 62366:2015, IEC 62304:2006, and IEC 60601-1, from which the 
following categories of anticipated VerTouch risks have been identified: 
• Failure to support proper identification of an insertion site (e.g. 
generates scanning output that is not uniform, aligned, or sufficiently 
sensitive)  
• Failure to support proper needle insertion (e.g. provides marker or 
needle guidance that is not accurate, precise, or intuitive) 
• Tissue trauma (e.g. causes needle dragging, or excessive levels of 
sustained force) 
• Standard risks associated with electromechanical medical devices 
(e.g. is not biocompatible, sterile, or electrically safe) 

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The first two categories could be associated with an increase in procedure 
time and/or an incorrect needle insertion. In nearly all indications, added time 
would not result in serious harm. If occurring in emergent cases, particularly 
in labor/delivery where the opportunity to administer anesthesia could be 
missed, the provider could revert to the manual procedure. In general, the 
consequence of an incorrect insertion associated with VerTouch would be 
identical to that with the standard of care. Namely, it would warrant 
reinsertions and/or redirections, which can be associated with certain adverse 
events that are possible in any neuraxial procedure, as listed in Section 9.3, 
most of which are very rare and/or have low prevalence. Among these, more 
severe harm exists in epidural and intrathecal injections, where incorrect 
insertion can result in incorrect administration of a drug or anesthetic. 
All risks belonging to the above categories will be reduced as far as possible 
via safety by design, protective measures, and information for safety. To 
mitigate the risk of device failure, design verification will be completed, 
including bench, usability, and standards testing, prior to study execution. 
Labeling will be provided to ensure proper use of all VerTouch components. 
As with the standard of care and the ultrasound alternative, IntuiTap has 
assessed the potential for risks in the above categories to be exacerbated by 
certain provider and/or patient characteristics. VerTouch formative and early 
IRB-approved testing, which has included residents (after their internship) 
through attendings, and non-MDs, has evidenced no significant difference in 
use errors and/or insertion performance associated with indicators of provider 
skill, such as provider level of training or experience with neuraxial 
procedures. However, to protect the direct risk to subjects, all Investigators 
will receive the same training on the use of the device and on study 
procedures, and must be approved by IntuiTap prior to enrollment. Training 
will follow a checklist that aligns with the IFU, and will include hands-on 
interaction with the Device. With regard to patient characteristics, formative 
testing has evidenced some challenges associated with using the Device in 
simulated patients with high BMI and/or in the lateral-decubitus position, but 
none that significantly impacted insertion performance. To mitigate these, the 
indications and instructions for use have been refined to ensure safe and 
effective Device use across indicated patients; and training will include 
simulated use in representative challenging cases. 
IntuiTap has also assessed and mitigated potential risks associated with the 
Device being left in place during needle insertion. For example, with an 
earlier version of the Device, there was a potential concern that while the 

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Device is still in place, it could obstruct the lumbar anatomy, precluding 
users from being able to confirm that their identified insertion site is aligned 
with the midline and at a safe vertebral level before they advance the needle 
at that site, possibly so deeply as to injure critical structures. This risk has 
been mitigated by the design and incorporation of the earlier-described 
Restrictor in the current Device, which limits the possible travel of an 
introducer or needle placed through the Device to a depth at which it is both 
safe and secure. After this depth is reached, the Device must be removed 
from the introducer or needle, such that the user has an unobstructed 
visualization of the insertion site before he/she continues advancing the 
needle. Section 9.2.1.1 details the evolution of the Restrictor. IntuiTap has 
also identified and mitigated any lower-level contributors to potential 
concerns about the Device being left in place during insertion. Among these 
are design specifications (and verification to these specifications) related to 
the level of stability and visibility when the device is in place; and the 
tolerance afforded to a needle during placement and Device removal. 
Importantly, the VerTouch IFU also includes an instruction for the use of 
standard landmarking techniques (i.e. palpation of the iliac crest) to identify a 
safe level for the procedure area prior to Device placement. 
9.2.1.1 Restrictor Discussion 
In the course of development, IntuiTap found that there are no 
anatomical structures in the region that are formally acknowledged as 
critical, and that needle depth has not been identified as an independent 
risk factor for any theoretical adverse events associated with placement 
of a spinal needle (such as retroperitoneal bleeding, epidural hematoma, 
and nerve root injury, identified in Section 9.3). However, in a 
conservative approach, IntuiTap designates a safe depth as within the 
posterior tissue shallower than the spinal landmarks, which includes 
skin, subcutaneous tissue, small blood vessels, and muscle, all of which 
are routinely pierced in neuraxial procedures, without significant and/or 
lasting damage[34-36]. The maximum depth is determined based on 
tissue thickness for the BMI expected with use of particular spinal 
needles, calculated using correlation coefficients provided by a study 
on spinal landmark depth[37]. Clinical users have expressed a desire for 
a minimum depth of 2.0cm or, alternatively, 30% of the needle shaft in 
order to feel that their introducer or needle is secure enough to remain 
in the tissue during Device removal. 

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Since most clinical participants in VerTouch testing have stated that 
they can determine a safe initial placement depth without the restrictor, 
based on training and skill in gauging needle depth by tissue 
consistency and resistance felt during placement, IntuiTap’s intent was 
to address this safety objective with minimal complexity and impact on 
existing workflow. To that end, Restrictor configurations were defined 
for the most commonly used needles for these procedures: introducers 
(1.25”), and 3.5” and 5” spinal needles (the 5” are a rare alternative to 
the 3.5”; used only in cases of morbid obesity). The design of the 
existing Needle Guide reduces the penetrable depth of any needle by 
2.0cm, which is what is needed to stop an introducer at the secure depth 
of 1.0cm. With the appropriate Restrictor configurations, the 3.5” and 
5” needles can reach depths of 2.0cm and 3.5cm respectively, which 
fall within the safe and secure range established by the above 
discussion. In the event that a provider opts to use a 5” needle in lower-
BMI cases, literature shows that it will still be prevented from reaching 
the epidural space, less conservatively allowing the needle to be placed 
through interspinous ligament, if BMI exceeds 20kg/m2; likewise for a 
3.5” needle in patients with less than 2.0cm subcutaneous tissue[11,38-40]. 
The Restrictor embodiment shown in Section 3.5 has been successfully 
tested in bench and usability studies. It is important to note that in this 
testing no significant difference has been observed in Device 
performance using the marking versus introducer or needle placement 
workflows (except where attributed to shortcomings in test 
methodology), despite the latter not enabling visual confirmation of the 
identified site until after the Device is removed. 
9.2.2 Medical Monitoring for Participant Safety 
The Principal Investigator will oversee the safety of the study, including 
careful assessment and appropriate reporting of adverse events as outlined in 
Section 9.4. Medical monitoring will include a regular assessment of the 
number and type of serious adverse events.  
Medical Monitor: 
 
ICON Clinical Research 
888-723-9952 (Telephone) 
 

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9.3 
Anticipated Adverse Events 
Anticipated adverse events are outlined below, with control rates listed separately 
as reported in the literature on LPs and neuraxial anesthesia. Few adverse events 
are associated with insertion attempts, and with the exception of unintended dural 
puncture, none have been directly tied to insertion depth (if performed at the correct 
vertebral level, below the cauda equina). It is important to note that the various risk 
factors associated with nearly all of these complications lead to great variability in 
reported rates. In particular, the incidence of most adverse events that can be linked 
to number of insertion attempts is directly correlated with needle characteristics, 
such as size and shape[8]. Additionally, rare complications have been found to be 
associated with the presence of spinal deformities, which are study exclusions[34,35].  
Adverse events associated with LPs include[41]: 
• PDPH, 40% (important risk factors include needle size and shape, use of 
stylet, patient position, number of attempts, and volume of CSF removed; 
may lead to the need for further treatment, including epidural blood 
patch)[42]  
• Cranial neuropathy, 0.4% 
• Paresthesia (nerve root irritation), 13%[43]  
• Low back pain, 35% 
• Bacterial meningitis, 0.2% 
• Intracranial bleeding, rare 
• Traumatic lumbar puncture, up to 72%, with 15.6% reported for cutoff of 
400 erythrocytes/µL in the first tube (in laboratory analysis, may lead to 
false-positive 
diagnosis 
of 
SAH 
or 
other 
cerebral 
vascular 
malformations)[43,44]  
• Retroperitoneal abscess, rare[45]  
• Spinal hematoma, rare 
Adverse events associated with neuraxial anesthesia include the following (rates are 
mostly reported for epidural anesthesia; where not specific to an epidural, rates are 
higher with spinal and combined spinal-epidural anesthesia)[46,47]: 
• Unintended dural puncture, 1.5% 
• Post-dural puncture headache, 0.21-1.5%  
• Spinal abscess, 0.0002% 
• High spinal block, 0.002% 
• Paresthesia (transient neurologic injury), 0.018%[9] 
• Spinal hematoma, 0.0002% 

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• Hypotension (requiring treatment), 30% 
• Persistent neurologic injury, 0.0004%[9]  
• Permanent neurological injury, 0.001% 
• Inadequate analgesic effect (failure), 6.3%  
• Pruritus, 12% 
• Backache, 12% 
• Nerve damage caused by needle trauma, 0.0006%  
• Epidural abscess, 0.003%  
• Bacterial meningitis, 0.003%  
• Epidural hematoma, 0.0006%  
• Fetal heart rate abnormalities: 5.5% 
• Fetal bradycardia: 4.7% 
9.4 
Adverse Event Reporting 
All Adverse Events occurring during the study period must be recorded. The 
clinical course of each event will be followed until resolution or stabilization, or 
until it has been determined that study treatment or participation is not the cause.  
The Investigator will promptly review documented adverse effects and abnormal 
test findings to determine:  
1)  
if the abnormal test finding should be classified as an adverse effect;  
2)  
if there is a reasonable possibility that the adverse effect was caused by the 
investigational device or, if applicable, other study treatment or diagnostic 
product(s); and  
3)  
if the adverse effect meets the criteria for a serious adverse effect. 
If the Investigator’s final determination of causality is “unknown and of 
questionable relationship to the investigational device or, if applicable, other study 
treatment or diagnostic product(s)”, the adverse effect will be classified as 
associated with the use of the investigational device for reporting purposes. If the 
investigator’s final determination of causality is “unknown but not related to the 
investigational device or, if applicable, other study treatment or diagnostic 
product(s)”, this determination and the rationale for the determination will be 
documented in the respective subject’s case history. 
9.4.1 Adverse Events 
All observed or volunteered adverse effects and abnormal test findings, 
regardless of treatment group, if applicable, or suspected causal relationship 
to the investigational device or, if applicable, other study treatment or 

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diagnostic product(s) will be recorded in the subjects’ case histories. For all 
adverse effects, sufficient information will be pursued and/or obtained so as 
to permit:  
1)  
an adequate determination of the outcome of the effect (i.e., whether 
the effect should be classified as a serious adverse effect) and;  
2) 
an assessment of the casual relationship between the adverse effect 
and the investigational device or, if applicable, the other study 
treatment or diagnostic product(s).  
Adverse effects or abnormal test findings felt to be associated with the 
investigational device or, if applicable, other study treatment or diagnostic 
product(s) will be followed until the effect (or its sequelae) or the abnormal 
test finding resolves or stabilizes at an acceptable level. 
Adverse Events that do not qualify as Serious Adverse Events, or as 
Unanticipated Adverse Device Effects will be reported to the Sponsor at a 
designated interval determined by the Sponsor. 
Adverse Events that do not qualify as Serious Adverse Events, or as 
Unanticipated Adverse Device Effects will be reported to the IRB with the 
continuing review progress report.  
9.4.2 Serious Adverse Events 
Investigators must report serious adverse events to the Study Sponsor or 
designee within 24 hours of learning of the event. A serious adverse event 
form must be completed by the Investigator and communicated to the Study 
Sponsor within 24 hours. Study Sponsor contact information for Serious 
Adverse Event Notification: 
 
 
ICON Clinical Research 
 
888-723-9952 (Telephone) 
 
At the time of the initial report, the following information should be 
provided: 
• Study Identifier 
• Whether study treatment was discontinued 
• Study Center 
• Reason the event is classified as serious 
• Subject Number 
• Investigator 
assessment 
of 
association 
between event and study device 
• Event Description 
• Date of Onset 
• Current Status 

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Serious Adverse Events that are at least possibly related must be reported to 
the IRB within 10 working days.  
9.4.3 Unanticipated Adverse Device Effects (UADE) 
Investigators are required to submit a report of a UADE to the Sponsor and 
the reviewing IRB as soon as possible, but in no event later than 10 working 
days after the Investigator first learns of the event.  
Sponsors must immediately conduct an evaluation of a UADE and must 
report the results of the evaluation to FDA, all reviewing IRBs, and 
participating Investigators within 10 working days after the Sponsor first 
receives notice of the effect. 
If the Adverse Event is Serious, Unanticipated, Device Related, and 
determined by the Sponsor to present an unreasonable risk to subjects, the 
Sponsor must terminate the study within 5 working days of that 
determination, and not later than 15 working days after the sponsor first 
received notice of the effect. 
10 
Classification as Non-Significant Risk Study 
The US Food and Drug Administration (FDA) has determined that the study may proceed 
under the non-significant risk (NSR) provisions of the IDE regulation.  
The rationale for the NSR classification of this study is that the investigational Device 
does not meet the definition of a significant risk (SR) device under 21 CFR 812.3(m), as 
further described below: 
• The Device is not an implant, nor does it present a potential for serious risk 
to the health safety, or welfare of a subject (812.3(m)(1));  
• The Device is not purported or represented to be for a use in supporting or 
sustaining human life, nor does it present a potential for serious risk to the 
health, safety, or welfare of a subject (812.3(m)(2));  
• The Device is not for a use of substantial importance in diagnosing, curing, 
mitigating, or treating disease, or otherwise preventing impairment of human 
health, nor does it present a potential for serious risk to the health, safety, or 
welfare of a subject (812.3(m)(3)); and 
• The Device does not otherwise present a potential for serious risk to the 
health, safety, or welfare of a subject (812.3(m)(4)). 
 

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As described in Section 9.2.1, the design of the Device and the procedures required by 
this protocol comprehensively mitigate and minimize potential risks to study subjects. 
Accordingly, the study is appropriately classified as an NSR study. As noted above, FDA 
has determined that the study may proceed under the NSR provisions of the IDE 
regulation without submission of an IDE application to FDA. 
  
11 
Data Handling and Record Keeping 
11.1 Confidentiality 
Information about study subjects will be kept confidential and managed according 
to the requirements of the Health Insurance Portability and Accountability Act of 
1996 (HIPAA). Those regulations require a signed subject authorization informing 
the subject of the following:  
• What protected health information (PHI) will be collected from subjects in 
this study 
• Who will have access to that information and why 
• Who will use or disclose that information 
• The rights of a research subject to revoke their authorization for use of their 
PHI.  
In the event that a subject revokes authorization to collect or use PHI, the 
investigator, by regulation, retains the ability to use all information collected prior 
to the revocation of subject authorization. For subjects that have revoked 
authorization to collect or use PHI, attempts should be made to obtain permission 
to collect at least vital status (i.e. that the subject is alive) at the end of their 
scheduled study period. 
11.2 Source Documents 
Source Data are the clinical findings and observations, laboratory and test data, and 
other information contained in Source Documents. Source Documents are the 
original records (and certified copies of original records); including, but not limited 
to, hospital medical records, physician or office charts, physician or nursing notes, 
subject diaries or evaluation checklists, pharmacy dispensing records, recorded data 
from automated instruments, x-rays, etc. When applicable, information recorded on 
the CRF shall match the Source Data recorded on the Source Documents. 

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11.3 Case Report Forms  
The study case report form (CRF) is the primary data collection instrument for the 
study. All data requested on the CRF must be recorded. All missing data must be 
explained. If a space on the CRF is left blank because the procedure was not done 
or the question was not asked, enter “N/D”. If the item is not applicable to the 
individual case, enter “N/A”.  
An electronic Case Report Form will be completed for each subject enrolled into 
the clinical study. All electronic records will be compliant to 21 CFR Part 11. The 
investigator will review, approve and sign/date each completed CRF; the 
investigator’s signature serving as attestation of the investigator’s responsibility for 
ensuring that all clinical and laboratory data entered on the CRF are complete, 
accurate and authentic.  
11.4 Clinical Reports 
An annual progress report will be submitted to the IRB by participating 
Investigators. Investigators will submit a final report of the clinical study to the 
sponsor and reviewing IRB within 3 months of termination or completion of the 
clinical study or the Investigator’s part of the clinical study.  
Sponsors will notify the FDA within 30 working days of the termination or 
completion of a significant risk clinical study. Sponsors will submit a final report to 
FDA, all reviewing IRBs and participating Investigators within 6 months of 
termination or completion. In the case of a non-significant risk study, the Sponsor 
shall submit a final report to all reviewing IRBs within 6 months after termination 
or completion. 
11.5 Records Retention  
The investigator will retain the specified records and reports for a minimum of 6 
years, or up to 2 years after the marketing application is approved for the 
investigational device; or, if a marketing application is not submitted or approved 
for the investigational device, until 2 years after investigations have been 
discontinued, whichever is longer. The Investigator will provide the Sponsor with 
written notice no less than 30 days prior to any scheduled destruction of records. 
12 
Study Monitoring, Auditing, and Inspecting 
This study will be monitored according to FDA/GCP guidelines. The Investigator will 
allocate adequate time for such monitoring activities. The Investigator will also ensure 
that the monitor or other compliance or quality assurance reviewer is given access to all 

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study-related documents and study related facilities (e.g. pharmacy, diagnostic 
laboratory, etc.), and has adequate space to conduct the monitoring visit. 
12.1 Study Monitoring Plan 
ICON will conduct monitoring visits at study initiation, study completion, and 
during the study as required. During these visits the monitor/s will review all 
aspects of the study to ensure that the protocol and applicable regulatory 
requirements and ISO 14155:2020 standard are adhered to. Monitoring activities 
will include checking CRFs and verifying data against source documentation, 
reviewing ICFs, checking the Device Accountability Log, and ensuring that the Site 
Study File is up to date and contains all the required documentation. ICON CRAs 
will contact sites regularly to ensure continuous oversight of study processes and 
follow-up on action items. Independent monitoring of the clinical study for clinical 
protocol compliance will be conducted periodically by qualified staff. In 
consideration of COVID-19 pandemic issues, where possible/feasible, remote 
source data verification, remote monitoring and remote investigational site closure 
visits may be employed. 
12.2 Auditing and Inspection 
The investigator will permit study-related monitoring, audits, and inspections by 
the IRB, the sponsor, government regulatory bodies, and institutional compliance 
and quality assurance groups of all study related documents (e.g. source 
documents, regulatory documents, data collection instruments, study data, etc.). 
The investigator will ensure the capability for inspections of applicable study-
related facilities (e.g. pharmacy, diagnostic laboratory, etc.). 
Participation as an investigator in this study implies acceptance of potential 
inspection by government regulatory authorities and applicable institutional 
compliance and quality assurance offices. 
13 
Administrative Study Information 
13.1 Technical Support 
In the event of a device malfunction, the Sponsor contact is Geoffrey Hutchins, 
Director of Engineering. He can be reached at 847-916-7074 during normal 
business hours, Central Time. Outside of these hours, a new device can be used 
until the Sponsor contact can be reached. 

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13.2 Pre-Study Site Qualification 
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 the 
protocol, including the protection of human subjects. Other site personnel must 
have appropriate research experience and infrastructure to ensure adherence to the 
protocol and enrollment of sufficient numbers of evaluable subjects. The 
curriculum vitae (CV) of the Investigator will be maintained in the Sponsor files as 
documentation of previous medical training, and federal databases will be searched 
to ensure that the Investigator and/or the site are not prohibited from engaging in 
federally Sponsored clinical research. The Principal Investigator will sign the 
signature page of this protocol, agreeing to comply with all applicable government 
regulations and the requirements of this study. 
13.3 Protocol Amendments After Study Initiation 
Should changes in the study plan or protocol become necessary in the course of the 
clinical trial, those specific changes will be discussed and agreed upon by the 
Sponsor, its acting representative if appropriate, Investigator, and appropriate IRB 
approval obtained before the changes are implemented. All changes must be 
documented as protocol amendments. For studies conducted under an IDE, FDA 
approval and/or notification may be required in addition to the IRB approval. 
13.4 Materials / Services Provided by Sponsor and Coordinating Center 
The Sponsor will provide the following materials and services: 
• VerTouch reusable and disposable components 
• Technical support as defined in Section 12.1 above 
• A dedicated PC laptop for study data (if necessary) 
14 
Ethical Considerations 
This study is to be conducted according to US and international standards of Good 
Clinical Practice, applicable government regulations (21 CFR 50, 54, 56 and 812) and 
Institutional research policies and procedures. 
This protocol and any amendments will be submitted to a properly constituted 
independent Institutional Review Board (IRB), in agreement with local legal 
prescriptions, for formal approval of the study conduct. The decision of the IRB 
concerning the conduct of the study will be made in writing to the investigator and a copy 
of this decision will be provided to the sponsor before commencement of this study.  

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15 
Study Finances 
15.1 Funding Source 
This study is funded by IntuiTap Medical, Inc. 
15.2 Conflicts of Interest 
Conflicts of interest or perceived conflicts of interest will be addressed in 
accordance with the policies of the participating institutions. The Sponsor will 
maintain Investigator Financial Statements as required by 21 CFR 54. 
16 
Publication Plan 
Neither the complete nor any part of the results of the study carried out under this 
protocol, nor any of the information provided by the sponsor for the purposes of 
performing the study, will be published or passed on to any third party without the 
consent of the study sponsor. Any investigator involved with this study is obligated to 
provide the sponsor with complete test results and all data derived from the study. 
17 
References 
1. 
Hall, M.J., DeFrances, C.J., Williams, S.N., Golosinskiy, A., & Schwartzman, A. 
(2010). National hospital discharge survey: 2007 summary. National Health 
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Osterman, M.J.K. & Martin, J.A. (2011). Epidural and spinal anesthesia use during 
labor: 27-state reporting area, 2008. National Vital Statistics Report, 59(5). 
3. 
Orthoworld (2012). Orthopaedic industry annual report: focus on joint replacement. 
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ADJADJ2012ADJADJorthoknow1206LXLXLXpdf 
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Pain Physician, 15(6), E969-E982. 
5. 
Robbins, E., & Hauser, S.L. (2015). Technique of lumbar puncture. In Kasper, D., 
Fauci, A.S., Hauser, S.L., Longo, D.L., Jameson, J.L., & Loscalzo, J. (Eds.), 
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6. 
Farley, A., & McLafferty, E. (2008). Lumbar puncture. Nursing standard, 22(22). 
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Bhattacharjee, S., & Kauer, G. (2013). A study on the standard of documentation of 
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8. 
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9. 
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hematoma, infection, and neurologic injury in obstetric patients with epidural 
analgesia/anesthesia. Anesthesiology, 105(2), 394-399. 
10. 
Cook, T.M., Counsell, D., & Wildsmith, J.A.W. (2009). Major complications of 
central neuraxial block: report on the Third National Audit Project of the Royal 
College of Anaesthetists. British Journal of Anaesthesia, 102(2), 179-190. 
11. 
Halpenny, D., O’Sullivan, K., & Burke, J.P., & Torreggiani, W.C. (2013). Does 
obesity preclude lumbar puncture with a standard spinal needle? The use of 
computed tomography to measure the skin to lumbar subarachnoid space distance 
in the general hospital population. European Radiology, 23(11), 3191-3196. 
12. 
Fryar, C.D., Carroll, M.D., & Ogden, C.L. (2016). Prevalence of overweight, 
obesity, and extreme obesity among adults aged 20 and over: United States, trends 
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m 
13. 
Kroll, H., et al (2015). Trends in lumbar puncture over 2 decades: a dramatic shift 
to radiology. American Journal of Roentgenology, 204, 15-19. 
14. 
The Joint Commission (2011). Radiation risks in diagnostic imaging. Sentinel 
Event Alert, 47. Retrieved from: https://www.wvdhhr.org/rtia/pdf/SEA_47[1].pdf 
15. 
Menger, R.P., Peyton, W.A., Hefner, M., Nanda, A, Cuellar, H. (2017). Economic 
outcomes of the addition of fluoroscopic guidance to the lumbar puncture 
procedure: a call for standardized training. Journal of Spine, 6(1). 
16. 
Gaskin, D.J., & Richard, P. (2012). The economic costs of pain in the United 
States. The Journal of Pain, 13(8), 715-724. 
17. 
Furness, G., Reilly, M.P., & Kuchi, S. (2002). An evaluation of ultrasound imaging 
for identification of lumbar intervertebral level. Anaesthesia, 57(3), 277-280. 
18. 
Dahiya, R.S., & Valle, M. (2013). Tactile sensing: definitions and classification. In 
Dahiya, R.S., & Valle, M. (Eds.), Robotic tactile sensing: technologies and system. 
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19. 
Pines, J.M., Batt, R.J., Hilton, J.A., & Terwiesch, C. (2010). The financial 
consequences of lost demand and reducing boarding in hospital emergency 
departments. Annals of Emergency Medicine, 58(4), 331-340. 
20. 
Nicks, B.A., & Manthey, D.M. (2012). The impact of psychiatric patient boarding 
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21. 
Falvo, T., Grove, L., Stachura, R., Vega, D., Stike, R., Schlenker, M., & Zirkin, W. 
(2007). The opportunity loss of boarding admitted patients in the emergency 
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22. 
Moskowitz, N.C., Traver, J., Garcia-Rojas, X., & Ganjeh, Y. (2018). 
US10004450B2: tactile sensing device for lumbar punctures. USPTO. 
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Moskowitz, N.C., Traver, J., Garcia-Rojas, X., Ganjeh, Y., Cruz, M., Plumb, J.R., 
Lowe, J.A., & Jones, A.K.G.P (2019). US10383610B2: Tactile sensing and needle 
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25. 
Chin, KJ, Perlas, A, Chan, V, Brown-Shreves, D, Koshkin, A, & Vaishnav, V 
(2011). Ultrasound imaging facilitates spinal anesthesia in adults with difficult 
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26. 
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27. 
Grau, T, Leipold, RW, Conradi, R, Martin, E, & Motsch, J (2002). Efficacy of 
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28. 
Lee, WS, Jeong, WJ, Yi, HY, Ryu, S, Lee, JW, & Kim, SW (2008). The usefulness 
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Hafezimoghadam, P, & Rezai, M (2013). Ultrasound guided lumbar puncture in 
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30. 
Nomura, JT, Leech, SJ, Shenbagamurthi, S, Sierzenski, PR, O'Connor, RE, 
Bollinger, M, & Gukhool, JA (2007). Journal of Ultrasound Medicine, 26(1), 
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31. 
Peterson, MA, Pisupati, D, Heyming, TW, Abele, JA, & Lewis, RJ (2014). 
Ultrasound for routine lumbar puncture. Academic Emergency Medicine, 21(1), 
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32. 
Singla, P, Dixon, AJ, Sheeran, JL, Scalzo, D, Mauldin, FW & Tiouririne, M 
(2019). Feasibility of spinal anesthesia placement using automated interpretation of 
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33. 
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34. 
Bruha, R, & Simon, S (1999). Lumbar puncture complicated by retroperitoneal 
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35. 
Aveline, C, & Bonnet, F (2004). Delayed retroperitoneal haematoma after failed 
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36. 
Myers, M, Meyers, L, & Fink, WA (2015). Extensive subarachnoid and epidural 
hematoma after lumbar puncture. Am J Emergency Medicine, 33. 
37. 
Kawchuk, GN, et al (2011). Spinal landmark depth in relation to body mass index. 
Manual Therapy, 16. 
38. 
Ravi, KK, et al (2011). Distance from skin to epidural space: correlation with body 
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40. 
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Evans, RW (1998). Complications of lumbar puncture. Neurologic clinics of North 
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Frank, RL (2008). Lumbar puncture and post-dural puncture headaches: 
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Shah, KH, Richard, KM, Nicholas, S, and Edlow, JA (2003). Incidence of 
traumatic lumbar puncture. Academic Emergency Medicine, 10(2): 151-154. 
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Boon, JM, Abrahams, PH, Meiring, JH, and Welch, T (2004). Lumbar puncture: 
anatomical review of a clinical skill. Clinical Anatomy, 17(1): 544-553.  
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Local and Regional Anesthesia, 3. 
 
 
 

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18 
Appendices and Attachments 
18.1 Subject Discomfort During Landmarking  
Subject discomfort will be assessed using a VAS as below. The scale is to be a total 
of 100 mm from 0 to 10. 
 
 
 
 
 
 
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
No 
Pain 
Mild 
Pain 
Moderate 
Pain 
Severe 
Pain 
Very 
Severe 
Worst
Possible
 
18.2 Provider Confidence 
Provider confidence in the identified insertion site will be assessed using a Likert 
scale as below. This scale is to be a total of 100 mm from 1 to 5. 
 
 
1 
Not At All 
Confident 
2 
Slightly 
Confident 
3 
Somewhat 
Confident 
4 
Fairly 
Confident 
5 
Completely 
Confident