Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement

Recruiting now

Conditions studied: Lumbar Spine Surgery

In brief

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.

Key facts

Study ID

NCT06020508

Run by

Hospital for Special Surgery, New York

People needed

36

Starts

2023-09-12

Expected to finish

2027-07-01

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Any patient undergoing a lumbar neuraxial procedure requiring epidural needle
• Age 18-99

You may not qualify if…

• 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

Where it is running

• Hospital for Special Surgery — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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