Clinical Trial

Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement

Recruiting
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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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-07 -> 2027-07 2026-08-11
minor Completion pushed: 2026-07 -> 2027-07 2026-08-11
Trial Details
NCT Number NCT06020508
Lead Sponsor Hospital for Special Surgery, New York
Conditions Lumbar Spine Surgery
Enrollment 36 participants
Start Date 2023-09-12
Primary Completion 2027-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-10