Clinical trial NCT04796935: A Study to Test Performance of Needle Placements for Neuraxial Procedures Using Tactile Imaging vs Control
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Nervous System Infections
Pseudotumor Cerebri
Neurological Disorder
Cancer
Obstetric Procedure Pain
Orthopedic Procedure Pain
Post-Dural Puncture Headache
Keywords: Diagnostic spinal puncture
Therapeutic spinal puncture
Lumbar puncture
Epidural
Neuraxial anesthesia
Blood patch
ESI
Lead sponsor: IntuiTap Medical, Inc
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2021-03-15
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An open-label, parallel, randomized study design
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Insertion Attempts
timeFrame: End of procedure, 1 per participant
Secondary outcomes:
measure: Incidence of First-insertion Success
timeFrame: End of procedure, 1 per subject
measure: Number of Redirections
timeFrame: End of procedure, 1 per subject
measure: Number of Passes
timeFrame: End of procedure, 1 per subject
measure: Incidence of First-pass Success
timeFrame: End of procedure, 1 per subject
measure: Subject Discomfort During Landmarking
timeFrame: End of procedure, 1 per subject
measure: Provider Confidence With the Identified Insertion Site
timeFrame: End of procedure, 1 per subject
Other outcomes:
measure: Localization Time
timeFrame: End of procedure, 1 per subject
measure: Insertion Time
timeFrame: End of procedure, 1 per subject
measure: Total Procedure Time
timeFrame: End of procedure, 1 per subject
measure: Bone Contacts
timeFrame: End of procedure, 1 per subject
measure: Incidence of Unintended Dural Puncture
timeFrame: End of procedure, 1 per subject
measure: Incidence of Paresthesia During Needle Insertion
timeFrame: End of procedure, 1 per subject
measure: Incidence of Traumatic Tap
timeFrame: End of procedure, 1 per subject
measure: Incidence of Referral to Radiology
timeFrame: End of procedure, 1 per subject
measure: Incidence of Conversion From Spinal to Epidural
timeFrame: End of procedure, 1 per subject
measure: Incidence of Post-dural Puncture Headache
timeFrame: Follow up, 3±2 days after procedure, 1 per subject
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
References: