Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement

Lumbar Spine Surgery Clinical Trial

Official title: Pilot Study for Human Clinical Trial to Evaluate the BRIGHTPOINT Reflectometer Device as Secondary Confirmation to Loss of Resistance in Lumbar Epidural Placement

Status Recruiting

Clinical Trial Summary

The goal of this clinical trial is to test the BrightPoint Epidural device as the first system to use multispectral reflectometry to find the epidural space in lumbar neuraxial procedures requiring epidural needle. The main questions it aims to answer are:

1. Is the device a qualitatively effective secondary confirmation of Loss of Resistance?

2. Is the device a qualitatively effective training tool for educating trainees in how to perform lumbar epidurals?

Participants will undergo a neuraxial procedure in which the attending anesthesiologist will use the BrightPoint epidural device to form an opinion on its effectiveness in confirming epidural space access.

Clinical Trial Description

There have been few improvements to the LOR technique from a device standpoint in recent years, and those that options do exist have not achieved widespread clinical use. The devices that do exist are variations on pressure sensors, some automate the "resistance" by placing various systems in place to apply a pressure to the plunger so that it will inject when the epidural space is accessed without the practitioner doing it themselves. This concept is represented by devices such as the Epimatic syringe from Vygon. Others improve on this concept by monitoring the pressure required to inject a set volume of fluid, thus being able to differentiate between true and false losses, as during false losses the pressure will increase as more fluid is injected. This system is represented by the CompuFlo Device by Milestone Scientific.

The BrightPoint Epidural device is the first system that utilizes multispectral reflectometry in order to identify the epidural space. This technology has the theoretical benefit over pressure-based systems of being able to identify and differentiate between different issue types (muscle, ligament, bone) as the needle is advanced towards the epidural space. Lumoptik, the company behind the BrightPoint Epidural device, is an early-stage startup based in Cleveland, Ohio. The main questions this trial aims to answer are:

1. Is the device a qualitatively effective secondary confirmation of Loss of Resistance?

2. Is the device a qualitatively effective training tool for educating trainees in how to perform lumbar epidurals?

This trial is being conducted to improve our current standard of care in neuraxial placement of loss-of-resistance. While the loss of resistance technique is tried and true, especially in experienced hands, complications such as dural punctures, misplaced epidurals, patchy epidurals, neurologic injuries, and intravascular catheters can occur even in experienced hands. All of which can cause significant patient morbidity and costs to the healthcare system, and as is shown in the Lacombe attached, the effects of dural puncture can be long lived for the patient. There can also be a steep learning curve when learning the technique, with the frequency of inadvertent dural punctures significantly higher in the early stages of learning the procedure. Therefore, we as a specialty are obligated to evaluate potential improvements to our current way of practice to reduce the burden to our patients from the complications of our interventions. ;

Related Conditions & MeSH terms

• Lumbar Spine Surgery

• NCT number: NCT06020508
• Study type: Observational
• Source: Hospital for Special Surgery, New York
• Contact: Justas Lauzadis, PhD
• Phone: 212-774-2946
• Email: lauzadisj@hss.edu
• Status: Recruiting
• Start date: September 12, 2023
• Completion date: April 2025