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RECRUITING
NCT06020508

Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement

Sponsor: Hospital for Special Surgery, New York

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

OBSERVATIONAL

Enrollment

36

Start Date

2023-09-12

Completion Date

2026-07

Last Updated

2025-12-16

Healthy Volunteers

Yes

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.

Locations (1)

Hospital for Special Surgery

New York, New York, United States