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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Central Nervous System Infections
- Sponsor
- IntuiTap Medical, Inc
- Enrollment
- 95
- Locations
- 3
- Primary Endpoint
- Number of Insertion Attempts
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study will compare the VerTouch device to the conventional palpation technique for performing diagnostic and therapeutic neuraxial procedures.
Detailed 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of Insertion Attempts
Time Frame: End of procedure, 1 per participant
Any forward movement of the needle following puncture of the skin, counted until confirmation of spinal canal access can be assessed.
Secondary Outcomes
- Incidence of First-insertion Success(End of procedure, 1 per subject)
- Number of Redirections(End of procedure, 1 per subject)
- Number of Passes(End of procedure, 1 per subject)
- Incidence of First-pass Success(End of procedure, 1 per subject)
- Subject Discomfort During Landmarking(End of procedure, 1 per subject)
- Provider Confidence With the Identified Insertion Site(End of procedure, 1 per subject)