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

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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group 1: Tactile Imaging (VerTouch); VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.	Device: Tactile Imaging (VerTouch); VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.
Active Comparator: Group 2: Control (palpation); Palpation used to identify and mark an insertion site.	Other: Control (palpation); Control, palpation used to identify and mark an insertion site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Insertion Attempts	Any forward movement of the needle following puncture of the skin, counted until confirmation of spinal canal access can be assessed.	End of procedure, 1 per participant

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Localization Time	Time from first touch of draped patient to identification of an insertion site; for VerTouch, this is the time from VerTouch device placement to movement of the applicator to the identified insertion site.	End of procedure, 1 per subject
Insertion Time	Time from retrieval of marker or local-anesthetic assembly until no further needle advancements are made.	End of procedure, 1 per subject
Total Procedure Time	From positioning of the patient to removal of the drape from the subject's back.	End of procedure, 1 per subject
Bone Contacts	Number of times the needle contacts bone, counted until confirmation of spinal canal access can be assessed.	End of procedure, 1 per subject
Incidence of Unintended Dural Puncture	A case that results in puncture of the dura when it is not intended (i.e., in an epidural procedure).	End of procedure, 1 per subject
Incidence of Paresthesia During Needle Insertion	A case in which paresthesia is experienced during needle insertion.	End of procedure, 1 per subject
Incidence of Traumatic Tap	A case that results in visible blood aspiration.	End of procedure, 1 per subject
Incidence of Referral to Radiology	A case in which the provider cannot perform the procedure at the bedside and refers the subject to radiology for the procedure to be completed under fluoroscopic guidance.	End of procedure, 1 per subject
Incidence of Conversion From Spinal to Epidural	A case that the provider opts to complete using epidural anesthesia instead of spinal anesthesia.	End of procedure, 1 per subject
Incidence of Post-dural Puncture Headache	A case that results in the patient experiencing one or more headache of any level of severity after the procedure and/or at follow-up.	Follow up, 3±2 days after procedure, 1 per subject

Collaborators and Investigators

• Sponsor: IntuiTap Medical, Inc
• Collaborators: ICON plc

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2021
• Primary Completion (Actual): November 24, 2021
• Study Completion (Actual): November 24, 2021

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 10, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 7, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Epidural; Lumbar puncture; Neuraxial anesthesia; Diagnostic spinal puncture; Therapeutic spinal puncture; Blood patch; ESI
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Infections; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Intracranial Hypertension; Nervous System Diseases; Headache; Pseudotumor Cerebri; Post-Dural Puncture Headache; Central Nervous System Infections
• Other Study ID Numbers: INT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes