NCT04796935

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: IntuiTap Medical, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
OTHER	Control (palpation)	Control, palpation used to identify and mark an insertion site.

Timeline

• Start date: 2021-04-04
• Primary completion: 2021-11-24
• Completion: 2021-11-24
• First posted: 2021-03-15
• Last updated: 2024-06-11
• Results posted: 2024-06-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study