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Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement
Sponsor: Hospital for Special Surgery, New York
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
Conditions
Interventions
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