Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement

Description

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.

Conditions

Lumbar Spine Surgery

Study Overview

Study Details

Study overview

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.

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

Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement

Condition
Lumbar Spine Surgery
Intervention / Treatment

-

Contacts and Locations

New York

Hospital for Special Surgery, New York, New York, United States, 10021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Any patient undergoing a lumbar neuraxial procedure requiring epidural needle
  • * Age 18-99
  • * Previous lumbar spine surgery
  • * Any known spinal abnormality that would interfere with successfully advancing a needle into the epidural space
  • * Any patient requiring epidural needle longer than 4 inches
  • * Any contraindication to neuraxial anesthesia
  • * Tattoo at the site of epidural insertion

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Hospital for Special Surgery, New York,

Michael Singleton, MD, PRINCIPAL_INVESTIGATOR, Hospital for Special Surgery, New York

Study Record Dates

2025-04