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

  • STATUS
    Recruiting
  • days left to enroll
    51
  • participants needed
    96
  • sponsor
    IntuiTap Medical, Inc
Updated on 12 August 2021
anesthesia

Summary

This study will compare the VerTouch device the conventional palpation technique for performing diagnostic and therapeutic neuraxial procedures.

Description

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 PDPHs; 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.

Details
Condition Central Nervous System Infection, Pseudotumor Cerebri, Cancer, nervous system disorder, Headache following lumbar puncture, Cancer/Tumors, Ewing's Family Tumors, Cancer (Pediatric), Neurologic Disorders, Neoplasms, post-dural puncture headache, primary cancer, primary malignant neoplasm, neurological disorders, neurological disorder, neurologic disorder, disorders of the nervous system, nervous system disease, neurological disease, nervous system disorders, malignancy, cancers, malignancies, malignant tumor, malignant tumors, cns infections, cns infection, infectious disease of central nervous system, Obstetric Procedure Pain, Orthopedic Procedure Pain
Treatment Device Group 1: Tactile Imaging (VerTouch), Group 2: Control (palpation)
Clinical Study IdentifierNCT04796935
SponsorIntuiTap Medical, Inc
Last Modified on12 August 2021

Eligibility

Yes No Not Sure

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
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