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

IntuiTap Medical

Status: Completed

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

Treatments: Device: Tactile Imaging (VerTouch); Other: Control (palpation)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04796935

INT-001

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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, 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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95 participants in 2 patient groups

Experimental Group 1: Tactile Imaging (VerTouch)

Experimental group

Description:

VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.

Treatment:

Device: Tactile Imaging (VerTouch)

Group 2: Control (palpation)

Active Comparator group

Description:

Palpation used to identify and mark an insertion site.

Treatment:

Other: Control (palpation)