Recruiting

Lumoptik Device

Sponsor:

Hospital for Special Surgery, New York

Code:

NCT06020508

Conditions

Lumbar Spine Surgery

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Group 1 - Lumoptik BrightPoint Epidural Device

Study Details

Brief 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

Study ID

NCT06020508

Start date

Sep 12, 2023

Status verified date

Nov, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

36 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1

Attending anesthesiologists who are trained in epidural placement will perform neuraxial procedures (CSEs, Epidural, Spinals through an epidural needle) utilizing loss of resistance with saline in conjunction with the Lumoptik BrightPoint Epidural Device. The Lumoptik device will be connected between a standard commercially available 17G or 18G, 3.5-inch epidural needle and a saline filled loss of resistance syringe. The anesthesiologist will view the Lumoptik BrightPoint visual display in real time as the epidural procedures are performed. The LOR epidural procedure using haptic feedback will be used as the primary confirmation of correct needle placement in the epidural space. Graphic and color circle information from the Lumoptik visual display will be used as a secondary confirmation of epidural placement.

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.

Primary outcome measure

  • Real time confirmation of epidural space with loss of resistance technique [ Time Frame: Post-operation (after the surgery is complete) ]

Central Contacts and Locations

Central contacts

Pa Thor, PhD

646-797-8535thorp@hss.edu

Maya Tailor

646-714-6828tailorm@hss.edu

Locations

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

Contacts

Justas Lauzadis, PhD

212-774-2946lauzadisj@hss.edu

Pa Thor, PhD

646-797-8535thorp@hss.edu

More Information

Sponsor

Hospital for Special Surgery, New York

Last update posted

Aug 10, 2026

Last verified

Nov, 2025

Keywords

  • epidural
  • neuraxial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hospital for Special Surgery, New York on 2026-08-10.