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

NCT ID: NCT04796935

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-04
• Study Completion Date: 2021-11-24

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Experimental Group 1: Tactile Imaging (VerTouch)

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

Group Type: EXPERIMENTAL

Tactile Imaging (VerTouch)

Intervention Type: DEVICE

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.

Group 2: Control (palpation)

Palpation used to identify and mark an insertion site.

Group Type: ACTIVE_COMPARATOR

Control (palpation)

Intervention Type: OTHER

Control, palpation used to identify and mark an insertion site.

Interventions

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.

Intervention Type: DEVICE

Control (palpation)

Control, palpation used to identify and mark an insertion site.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ICON plc

INDUSTRY

Sponsor Role: collaborator

IntuiTap Medical, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rhode Island Hospital

Providence, Rhode Island, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Texas Health Science Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

INT-001

Identifier Type: -

Identifier Source: org_study_id