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Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement

NCT06020508 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2025-12-16

No results posted yet for this study

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.

Conditions

  • Lumbar Spine Surgery

Interventions

DEVICE

Group 1 - Lumoptik BrightPoint Epidural Device

Participants will undergo a neuraxial procedure to measure loss of resistance with saline in conjunction with the Lumoptik BrightPoint Epidural Device.

Sponsors & Collaborators

  • Hospital for Special Surgery, New York

    lead OTHER

Principal Investigators

  • Michael Singleton, MD · Hospital for Special Surgery, New York

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-12
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06020508 on ClinicalTrials.gov