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

Not Applicable

Completed

• Conditions: Pseudotumor Cerebri; Obstetric Procedure Pain; Post-Dural Puncture Headache; Cancer; Central Nervous System Infections; Neurological Disorder; Orthopedic Procedure Pain
• Interventions: Other: Control (palpation); Device: Tactile Imaging (VerTouch)

• Registration Number: NCT04796935
• Lead Sponsor: IntuiTap Medical, Inc

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.

Study Timeline

• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-10
• Study First Posted: 2021-03-15
• Study Start: 2021-04-04
• Primary Completion: 2021-11-24
• Study Completion: 2021-11-24
• Disposition First Submitted: 2022-11-22
• Results First Submitted: 2024-01-02
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-04
• Results First Posted: 2024-06-06
• Disposition First Posted: 2024-06-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Control (palpation)	Control (palpation)	Palpation used to identify and mark an insertion site.
Experimental Group 1: Tactile Imaging (VerTouch)	Tactile Imaging (VerTouch)	VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.

Primary Outcome Measures

Name	Time	Method
Number of Insertion Attempts	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 Outcome Measures

Name	Time	Method
Incidence of First-insertion Success	End of procedure, 1 per subject	A case that does not require any reinsertions, but can include any number of redirections.
Number of Redirections	End of procedure, 1 per subject	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.
Number of Passes	End of procedure, 1 per subject	Any forward movement of the needle, calculated as the sum of insertions and redirections.
Incidence of First-pass Success	End of procedure, 1 per subject	A case that does not require reinsertions or redirections.
Subject Discomfort During Landmarking	End of procedure, 1 per subject	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.
Provider Confidence With the Identified Insertion Site	End of procedure, 1 per subject	Evaluated using a 1-5 point Numeric Rating Scale where 1 is equivalent to not at all confident and 5 equivalent to completely confident.

Trial Locations

Locations (3)

University of Texas Health Science Center; 🇺🇸 Houston, Texas, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States