Does the VerTouch Device Improve Insertion Site Identification for Lumbar Neuraxial Procedures When Compared to Palpation or Ultrasound Guided Site Selection? A Prospective Randomized Controlled Trial
Phase: NA
Conditions: Pregnancy, Pain
Sponsor: Northwestern University

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PROTOCOL TITLE: Does the VerTouch Device Improve Insertion Site Identification for 
Lumbar Neuraxial Procedures when Compared to Palpation or Ultrasound Guided Site 
Selection? A Prospective Randomized Controlled Trial 
 
 
PRINCIPAL INVESTIGATOR: 
 
Mahesh Vaidyanathan, M.D. 
Department of Anesthesiology 
(312) 695-2500 
mahesh.vaidyanathan@northwestern.edu 
 
 
VERSION DATE:  1.1 03/26/2021 
 
  
STUDY SUMMARY: 
 
Investigational Agent(s)  
(Drugs or Devices) 
Intuitap VerTouch Device 
IND / IDE / HDE #   
Indicate 
Special Population(s) 
   Children  
   Children who are wards of the state  
    Adults Unable to Consent   
    Cognitively Impaired Adults  
    Neonates of Uncertain Viability  
 x Pregnant Women  
    Prisoners (or other detained/paroled individuals)  
    Students/Employees  
Sample Size 120 
Funding Source Intuitap Medical 
Indicate the type of consent 
to be obtained 
 x Written  
    Verbal/Waiver of Documentation of Informed Consent 
    Waiver of HIPAA Authorization  
    Waiver/Alteration of Consent Process   
Site  Lead Site (For A Multiple Site Research Study) 
 Data Coordinating Center (DCC) 
Research Related Radiation 
Exposure 
   Yes  
 x No  
DSMB / DMC / IDMC  Yes  
x No 

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OBJECTIVES: 
Is there an identifiable difference in the number of insertions and redirections of the needle for a 
lumbar neuraxial procedure when the VerTouch device is used, instead of palpation (current 
gold standard) or ultrasound guidance (US), for the identification of the procedural insertion 
site?  
 
Null Hypothesis: 
There is no difference in the number of insertions and redirections of the needle for a lumbar 
neuraxial procedure when the VerTouch device is used.  
 
 
BACKGROUND: 
Literature:  
Neuraxial procedures are performed across a myriad of clinical scenarios. From spinal anesthe-
sia for caesarian sections, to epidural anesthesia for labor pain and abdominal surgery, to lum-
bar punctures and lumbar drain placements for the diagnosis and management of neurologic 
illness, accessing the spinal cord and surrounding structures is commonplace in many busy 
hospitals. Anesthesiologists, neurologists, neurosurgeons, emergency physicians, and other 
providers learn and perform neuraxial access with meticulous precision and attention to detail to 
avoid damaging the spinal cord. The best-in-breed methods for ensuring safety continue to rely 
on provider experience and palpation (using the fingers) of the back and surrounding land-
marks. Some practitioners use ultrasound, which is bulky, costly, and requires yet additional 
training. As such, the safety of these procedures has plateaued. They are not unsafe by any 
means – the rates of complications can be as low as in the single digits of percentage when per-
formed by an experienced provider. A new device (the VerTouch), holds promise to reduce the 
complication rate for the first time in years, as well as allow providers with significantly less train-
ing to achieve the same, low complication rate. 
 
VerTouch incorporates tactile sensing—a form of electronic palpation—to detect spinal land-
marks, analogous to those sensed during manual palpation. This technology is most prevalent 
in robotics, but has recently been applied as a clinical-imaging tool in breast, prostate, and other 
soft-tissue applications. The device comprises an array of pressure sensors—also known as 
force-sensing resistors—which, when pressed against the back, measure the distribution of me-
chanical stress across the compressed tissue. These data are processed and communicated to 
the device’s display as a full-color, 2D pressure map of patient anatomy. Regional differences in 
elasticity/hardness are observed as gradations between deep blue (for areas of low firmness) to 
red (for areas of higher firmness, e.g. bone). 
 
In this project we aim to compare the VerTouch device to palpation and US techniques used to 
identifying the anatomic landmarks and optimal location for neuraxial access. In a previous fea-
sibility study completed here at Northwestern University (NU) in Prentice Women’s hospital 
(stu#: 00207454), the researchers showed that when VerTouch was used to mark a site prior to 
the neuraxial procedure, and the site marked was eventually used for the procedure, the suc-
cess rate of the procedure with minimal needle manipulation was greater than historical data for 
the gold standard palpation technique. Additionally, the provider confidence in the information 
provided by the device was greater than 95% (abstract and/or submitted manuscript for this 
study can be provided on request). The proposed RCT herein will be a prospective comparison 

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of the now proven VerTouch device to the gold standard of palpation and the commonly cited 
US techniques.  
 
SIGNIFICANCE: 
Thousands of neuraxial procedures are completed daily with over 12,000 done at Prentice 
Women’s hospital last year. These procedures are not without difficulty and complication. The 
gold standard of palpation and blind advancement of the needle toward the spine can result in 
multiple insertions of the needle into the skin and redirections of the trajectory of that needle af-
ter insertion to avoid the bones of the spine protecting the spinal column. These insertions and 
redirections are not only time consuming while the patient is in an uncommon position, but they 
also cause discomfort and possibly lasting pain days after the procedure. In addition to the pa-
tient dynamics, when anatomical or positioning issues result in difficult neuraxial procedures the 
common teaching is to attempt US guided access. Unfortunately, not many proceduralist are 
trained in this modality and the additional materials needed to perform the procedure with US 
take time to gather and further prolong the procedure. Additionally, though the cost of US tech-
nology is getting more reasonable, it is still rather expensive and a barrier to utilization by many 
facilities around the country and the world. Often, after many attempts, the proceduralist accepts 
failure of the procedure and refers the patient to the interventional radiology (IR) or pain medi-
cine specialist for completion of the procedure using radiation to visualize the spine. Note, this is 
not an option for pregnant women who are not eligible for radiation due to fetal concerns. 
 
The VerTouch offers a non-invasive, untethered, and non-radiation producing device that allows 
for the visualization of the underlying structures of the spine to determine ideal needle place-
ment for neuraxial procedures. The output on the screen can also be visualized by other provid-
ers or senior proceduralist for assistance with best course of action for the procedure. The de-
vice does not cause discomfort to the patient and does not require any additional materials to be 
functional.  
 
This study has the potential to show that the VerTouch is more effective than palpation and as 
effective as US at defining the location for neuraxial procedure initiation and eventual success. If 
the VerTouch device is capable of improving the consistency of success of neuraxial proce-
dures, while minimizing need for costly and cumbersome US technology and decreasing referral 
to radiation requiring procedures, the benefit to patients and proceduralists would be exponen-
tial. 
 
STUDY ENDPOINTS: The primary endpoint is the combined total number of insertions or 
redirection of the needle being used for the procedure. 
The endpoint is when all the subjects for each arm have been recruited and completed study 
procedures. 
 
STUDY INTERVENTION(S)  / INVESTIGATIONAL AGENT(S): 
We will use the VerTouch device which we have shown to be a non-significant risk device (IDE). 
It is comprised of a non-invasive pressure sensor that is gently pushed against the back, with a 
screen that reads out the pressure being applied across the device. Areas of higher pressure 
are suggestive of bony areas, whereas areas of lower pressure are more likely tissue. The ap-
plication of the device to the body is less obtrusive than ultrasound, which is commonly used, 
because this device does not use any gel or other medium. 
 
The device will be stored in a locked space only accessible to the proceduralist or research per-
sonnel authorized to prepare the device for use. The device is self-contained and powered by 
an internal rechargeable battery. The device will only be at the bedside for those subjects that 

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have been recruited to participate. In order to maintain blinding, even if the device is not used 
for the recruited patient it will be at the bedside to ensure the observers are not un-blinded.  
 
PROCEDURES INVOLVED: 
 
The study participants will be recruited in two parallel cohorts – pregnant patients and non-preg-
nant patients. Pregnant patients tend to be healthy and without comorbidities, and the providers 
(anesthesiologists) that perform the neuraxial procedure tend to have significant experience. 
Non-pregnant patients tend to require neuraxial access for diagnostic or therapeutic purposes 
(i.e. not for the relief of labor pains), and therefore have comorbidities. Additionally, these pro-
viders (ER, neurology, etc.) tend to do far less of these procedures. Together, these two tracks 
provide the breadth of neuraxial access and therefore maximally determine early feasibility of 
this device.  
 
For both pregnant and non-pregnant patients, the study procedure is the same. Eligible patients 
will be identified by chart review of various elements of the electronic medical record, as follows: 
 
Labor & Delivery: Patients will be identified in communication with the OB anesthesia team that 
maintains an “electronic tracking board” in the interdisciplinary workroom in Prentice. Only pa-
tients early in labor, who are in relatively low amounts of pain and distress, will be approached 
by OB Anesthesia research nurses about the study. If the patient agrees to participate in the 
study she will be randomized that time to one of the three arms (palpation, US, or VerTouch).  
 
Lumbar Puncture: Patients scheduled to undergo diagnostic or therapeutic lumbar puncture 
will be identified by appointment schedule and chart review. If a patient is determined to be eligi-
ble for the study by the provider responsible for the procedure the patient will be approached 
once availability of the study team is confirmed. The study team will arrange to be present for 
the procedure at the scheduled appointment time. The proceduralist or study team member will 
consent the patient, and if the patient agrees to participate in the study he/she will be random-
ized that time to one of the three arms (palpation, US, or VerTouch). 
 
Randomization: 
Prospective, randomized, controlled, observer blinded trial in patients undergoing neuraxial pro-
cedures for diagnostic, therapeutic, primary surgical anesthesia or labor pain management.  
 
Group #1:  VerTouch utilized for identification of site for labor epidural or spinal anesthesia pro-
cedure 
 
Group #2:  Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthe-
sia procedure 
 
Group #3:  Control group, palpation utilized for identification of site for labor epidural or spinal 
anesthesia procedure 
 
Group #4:  VerTouch utilized for identification of site for lumbar puncture procedure 
 
Group #5:  Ultrasound (US) utilized for identification of site for lumbar puncture procedure 
 
Group #6:  Control group, palpation utilized for identification of site for lumbar puncture proce-
dure 

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Participants will be randomized to treatment groups based on a random computer-generated 
schedule (https://www.randomizer.org). Proceduralists will not be blinded to randomization, 
however blinded research personnel will observe the procedure after site determination and col-
lect all outcome measures in this study. 
 
For groups 1-3, on request of neuraxial procedure the research nurse and proceduralist willh 
proceed to the patient’s room with all normal supplies in addition to the VerTouch and US ma-
chine designated for this study. The research nurse will then un-blind to proceduralist to the pa-
tient’s group and site identification will proceed. Regardless of the group, the proceduralist will 
make a mark at the site identified for the procedure using a chlorhexidine safe surgical marking 
pen. After completion of marking, the research nurse will notify the observer that they may enter 
the room to observe the procedure and collect the relevant data. Observers will be limited to 
3observers, and additionally inter-observer variability will be minimized using video corrobora-
tion of at least 10 procedures. 
 
If one of the blinded study observers is not readily available due clinical responsibilities, the re-
search nurse will video record the procedure per protocol. The procedure video will be reviewed 
by the blinded observer and the number of redirections and reinsertions will be counted and re-
layed to the research nurse for completion of data collection. 
 
For groups 4-6, once the patient is in the procedural suite the proceduralist will be un-blinded. 
He/she will proceed to mark the patient with the appropriate modality determined by the group 
number. After marking, the proceduralist will allow the research observer to enter the room to 
observe the procedure and collect the relevant data. Observers will be limited to 3 observers, 
and additionally inter-observer variability will be minimized using video corroboration of at least 
10 procedures. 
 
All standard procedures for neuraxial procedures will be followed (standard practice) after site 
determination including time out, skin prep, hemodynamic monitoring, post-procedure instruc-
tion etc. 
 
Zoomed in audio-less video of the procedure sight will be collected during at least 10 of the pro-
cedures, at each site, for inter-observer variability determination. If the subject has any identify-
ing marks in or near the procedure site or refuses video capture of the procedure no video or 
images will not be collected in that subject. If the blinded observer is not present and the proce-
dure cannot be recorded for any of the above reasons, the patient will be removed from the 
study. 
 
 
Data collected on the VerTouch device will only be associated with the subject number when 
collected from device for technical evaluation of pressure sensor performance. 
 
If US is used the provider chooses to save an image of the anatomy visualized the research 
nurse or staff will save that image under the subject number for post-hoc analysis of anatomy 
identified and image quality achieved. 
 
 
DATA AND SPECIMEN BANKING 

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 We will collect and data including reason for procedure, type of procedure, any anatomical is-
sues affecting procedure (including but not limited to: scoliosis, positioning, BMI, paralysis), and 
age. The video/images collected will allow us to compare the observer variability.  
 
SHARING RESULTS WITH PARTICIPANTS 
Results will not be shared with participants. 
 
STUDY TIMELINES 
The individual will participate in the study for the duration of the procedure, which is usually ap-
proximately half an hour. It will take approximately one year to enroll all participants, and ap-
proximately 3 months to perform data analysis.  
 
INCLUSION AND EXCLUSION CRITERIA 
 
Inclusion criteria are any adult patients undergoing a neuraxial procedure. Necessary to this is 
the inclusion of pregnant women who make up a significant fraction of neuraxial procedures.  
 
Exclusion criteria are those patients who do not speak English, have a plastic allergy, or are un-
able to consent.  
 
Other special populations (individuals who are not yet adults, prisoners, vulnerable populations) 
will also be excluded. 
 
If it is impossible to take a photograph that does not include identifying marks on the back (i.e. a 
birthmark or tattoo) the patient will be excluded from the video portion of the study 
 
 
VULNERABLE POPULATIONS 
Pregnant women will be included in the study because they make up the primary population that 
will benefit from the success of this device. As otherwise young and healthy females, they also 
represent a group that, if a serious adverse effect of neuraxial access were to occur, could re-
sult in significantly lifelong morbidity. 
 
The device has been tested on cadavers, 5 healthy subjects to prove sensor function, 8 healthy 
subjects who did not undergo a procedure to prove limited congruence with palpation, and 10 
healthy subjects that did not undergo procedure to prove feasibility of functional design. 
 
At this time the device needs to be tested in a setting where patients are undergoing proce-
dures, and that is the purpose of this study. It is critical that the study contain pregnant women 
in the population as they receive the highest rate of neuraxial procedures, have significantly dif-
ferent anatomy than the general population and stand to gain the most from the success of the 
device. If this device were to be successful in identifying the optimum needle placement for epi-
dural placement in pregnant women, this could one day significantly reduce the discomfort and 
possible side effects of neuraxial procedures in pregnant women. Notably, a relatively large per-
centage (up to 5%) of women will experience a significant headache after neuraxial access due 
to “blind” needle guidance. This can be debilitating, especially in the setting of labor and birth. 
This non-invasive, inexpensive device holds promise to one day reduce this morbidity and 
therefore significantly improve the experience of these women during the birth of their child. 
 
 

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HRP 412 has been reviewed 
  
  
 
PARTICIPANT POPULATION(S) 
Accrual Num-
ber: 
Category/Group: 
(Adults/Children 
Special/Vulnerable 
Populations) 
Consented: 
Maximum Number to be Con-
sented or Reviewed/Col-
lected/Screened 
Enrolled: 
Number to Complete 
the Study or Needed 
to Address the Re-
search Question 
Local 
Pregnant Women 
60 
60 
Adults 
60 
60 
Study-wide 
 
 
 
 
 
 
Total: 
 
120 
120 
 
 
 
RECRUITMENT METHODS 
Patients will be identified by the anesthesiology team by chart review after the team has been 
alerted to the need for pain management and approached in person to be recruited. 
  
The source of participants will be Prentice Women’s Hospital and NM (Galter, Feinberg, Lavin) 
pavilions. 
 
COMPENSATION FOR PARTICIPATION IN RESEARCH ACTIVITIES 
There will be no compensation for participation. 
 
WITHDRAWAL OF PARTICIPANTS 
Patients can withdraw from the study at any time and their data will be deleted, and in no way 
will this impact their care since the study explicitly does not affect the standard of care. The 
study team will notify the PI by secure NM or NU email if a subject withdraws from the study. 
 
RISKS TO PARTICIPANTS 
No significant risk to the patient exists with the utilization of the VerTouch device. The materials 
on the device that come in contact with the patient are similar or the same as those that make 
up the US probes used in current state. The device is non-invasive and does not generate radi-
ation or any other emission that would affect he patients skin or underlying tissues. 
 
POTENTIAL BENEFITS TO PARTICIPANTS 
While there is no direct benefit to participants, we do hope that this will benefit pregnant and 
non-pregnant patients in the future who are undergoing neuraxial procedures. Our previous fea-
sibility study did suggest that the use of the VerTouch may represent an improvement on the 
current gold standard of palpation. 
 
DATA MANAGEMENT AND CONFIDENTIALITY 

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Based on the feasibility study data collected and published earlier this year at our institution the 
incidence of first insertion success when utilizing the VerTouch device is 90.1%. Using historical 
data from studies comparing Ultrasound to Palpation the first insertion success rates are 62.9 
and 43.6%, respectively. When utilizing the anticipated incidence of first insertion success for 
the VerTouch device and Ultrasound to complete a sample size calculation, given Type 1 and 
Type 2 error are 0.05 and 80%, respectively, each group must contain 38 patients. Therefore, 
when including the control "palpation" group, the total population needs to be 114 patients. We 
plan to recruit 120 patients, 40 in each group, to ensure appropriate sample size and allow un-
known possible exclusions of recruited patients." 
 
All photographs will be maximally zoomed in. If it is impossible to take a video that does not in-
clude identifying marks on the back (i.e. a birthmark or tattoo) no image will be taken. Data will 
be stored in REDcap using NM password protected computers for data entry. 
Data in REDcap is backed up nightly using NM servers which are only accessible to the NM IT 
administrator. Data in REDcap and pictures/videos will be destroyed 5 years after the comple-
tion of the study.  
 
Statistical analysis: Data will be compared between groups using the chi2 statistic or the 
Fisher’s exact test. A P < 0.05 will be required to reject the null hypothesis. 
 
 
PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF PARTICIPANTS 
N/A (minimal risk study) 
 
PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS 
Patients in this study, whether undergoing neuraxial access for a disease-state or for the treat-
ment of labor pains, will certainly be under some amount of stress. Having a needle placed into 
one’s back, as is the case for neuraxial procedures, can be stress provoking. Extra care will be 
taken to approach them during a quiet moment when the clinical team has finished their evalua-
tion.  It will be emphasized that in no way will this impact their care, and in fact can help future 
patients undergo these procedures more quickly and safely to minimize their stress. 
 
COMPENSATION FOR RESEARCH-RELATED INJURY 
N/A  
 
 
ECONOMIC BURDEN TO PARTICIPANTS 
There is no cost to the patient to be in this study. 
 
 
CONSENT PROCESS 
 
Consent will take place in Prentice Women’s Hospital 8th floor Labor and Delivery unit at a time 
mutually convenient to the clinical team, patient, and research team. Subjects will also be re-
cruited from Galter, Lavin and Feinberg pavilions (numerous medical units). They will be offered 
to contemplate their participation up until 10 minutes prior to the time of their neuraxial proce-
dure (if any less than 10 minutes were available for application of the VerTouch device prior to 
the clinical procedure, this would risk rushing the clinical procedure). REDcap electronic consent 
will be utilized to decrease the number of times the paper consent would be touched.   Multiple 

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times throughout the process, the participant will be reminded that this in no way affects their 
standard of care and that participation can be withdrawn at any time. 
 
NON-ENGLISH SPEAKING PARTICIPANTS 
N/A 
 
 
WAIVER OR ALTERATION OF CONSENT PROCESS  
N/A 
PROTECTED HEALTH INFORMATION (PHI AND HIPAA) 
Does the study involve the creation, use, or disclosure of Protected Personal Health In-
formation? 
- Will a HIPAA Authorization be obtained from for all participants? Yes 
-  
- Name 
- Age (years) 
- Date of procedure 
- Telephone numbers 
- Medical Record Numbers 
- Email address 
 
 
QUALIFICATIONS TO CONDUCT RESEARCH AND RESOURCES AVAILABLE 
 
The PI has 10 plus years clinical research experience. Prentice Women’s Hospital cares for 
over 12,000 women a year for childbirth. Over 90 percent request pain management using An-
esthesiology services for epidural catheter placement for pain relief. The research team includes 
8 nurse clinicians in the Anesthesia care team who will assist the PI during the study period. 
 
In the event of an inadvertent dural puncture the study team and PI will contact the anesthesiol-
ogy team to follow up with the subject for the next 5 days to assess for complications.  
 
MULTI-SITE RESEARCH N/A