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

NCT04796935 | Completed Results FDA Device

• 1 other identifier: INT-001
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 3

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Other Outcomes (10)

• Localization Time

  End of procedure, 1 per subject

• Insertion Time

  End of procedure, 1 per subject

• Total Procedure Time

  End of procedure, 1 per subject

Study Arms (2)

Experimental Group 1: Tactile Imaging (VerTouch)

EXPERIMENTAL

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

Device: Tactile Imaging (VerTouch)

Group 2: Control (palpation)

ACTIVE COMPARATOR

Palpation used to identify and mark an insertion site.

Other: Control (palpation)

Interventions

Tactile Imaging (VerTouch) 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.

Experimental Group 1: Tactile Imaging (VerTouch)

Control (palpation) OTHER

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

Group 2: Control (palpation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IntuiTap Medical, Inc: lead
• ICON plc: collaborator

Study Sites (3)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Central Nervous System Infections; Pseudotumor Cerebri; Nervous System Diseases; Neoplasms; Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Infections; Central Nervous System Diseases; Intracranial Hypertension; Brain Diseases; Headache Disorders, Secondary; Headache Disorders

Limitations and Caveats

The enrollment period (April 2021-November 2021) was closed due to COVID concerns prior to reaching 96 evaluable subjects. Due to limitations in the emergency medicine setting at one site, emergency medicine providers at that site performed procedures for approximately half of the subjects enrolled in that site's neurology setting. Due to scheduling limitations, only MDs (including residents) performed procedures, and not all providers had the opportunity to use the device more than once.

Results Point of Contact

• Title: Keri Urwin
• Organization: Elevate Clinical Consulting

kurwin@elevateclinicalconsulting.com

919-247-8845

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An open-label, parallel, randomized study design

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 15, 2021
• Study Start: April 4, 2021
• Primary Completion: November 24, 2021
• Study Completion: November 24, 2021
• Last Updated: June 11, 2024
• Results First Posted: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)