A Study to Test Performance of Needle Placements for Neuraxial Procedures Using Tactile Imaging vs Control

Study Overview
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Brief Summary
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This study will compare the VerTouch device to the conventional palpation technique for performing diagnostic and therapeutic neuraxial procedures.

Detailed Description
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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. 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. 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. These attempts lead to patient pain and complications, such as traumatic taps and post-dural puncture (PDPH) headaches; unpredictable procedure times; and poor facility throughput. The VerTouch device uses tactile imaging to offer a non-invasive, untethered, non radiation-producing solution for visualizing spinal anatomy in order to identify an ideal location for needle placement in a neuraxial procedure. The device can be used to mark the identified site with a surgical marker, or to begin placement of a needle or introducer at that site. Study participants will be recruited in two parallel cohorts: the control (palpation) group or the tactile imaging (VerTouch) group, further stratified by procedure setting, including emergency medicine, neurology, and anesthesiology. Once an insertion site is marked with a marker or shallow placement of a needle or introducer, the procedure will continue in the usual manner for subjects in both groups.

Official Title
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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

Conditions
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Central Nervous System Infections, Pseudotumor Cerebri, Neurological Disorder, Cancer, Obstetric Procedure Pain, Orthopedic Procedure Pain, Post-Dural Puncture Headache

Intervention / Treatment
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* Device: Tactile Imaging (VerTouch)
* Other: Control (palpation)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females aged 18 years and above, inclusive 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, 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) Subjects having a BMI ≤42kg/m2 Exclusion Criteria: Patient does not provide informed consent Skin or soft tissue infection near the puncture site Allergy to local anesthetic Uncorrected coagulopathy Acute spinal cord trauma History of lumbar spinal surgery Prior known failed neuraxial anesthesia Diagnosed scoliosis, thoracic kyphosis, lumbar lordosis, scleroderma, or ankylosing spondylitis, or lumbar spinal stenosis Incarcerated subjects

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: An open-label, parallel, randomized study design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group 1: Tactile Imaging (VerTouch)<br>VerTouch used to identify and mark, or begin placement of a needle, at an insertion site. | Device: Tactile Imaging (VerTouch)<br>* VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.<br>|
| Active Comparator: Group 2: Control (palpation)<br>Palpation used to identify and mark an insertion site. | Other: Control (palpation)<br>* Control, palpation used to identify and mark an insertion site.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of insertion attempts | Any forward movement of the needle following puncture of the skin, counted until confirmation of spinal canal access can be assessed. | End of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of first-insertion success | A case that does not require any reinsertions, but can include any number of redirections. | End of procedure | 
| 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. | End of procedure | 
| Number of passes | Any forward movement of the needle, calculated as the sum of insertions and redirections. | End of procedure | 
| Incidence of first-pass success | A case that does not require reinsertions or redirections. | End of procedure | 
| Subject discomfort during landmarking | Evaluated using a 10-point Numeric Pain Rating Scale, where 1 is equivalent to no pain and 10 is equivalent to the worst possible pain. | End of procedure | 
| Provider confidence with the identified insertion site | Evaluated using a 1-5 point Numeric Rating Scale where 1 is equivalent to not at all confident and 5 equivalent to completely confident. | End of procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESI, Diagnostic spinal puncture, Therapeutic spinal puncture, Lumbar puncture, Epidural, Neuraxial anesthesia, Blood patch