Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement

NCT06020508 | Recruiting DMC FDA Device

• 1 other identifier: 2023-0074
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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. 1.Is the device a qualitatively effective secondary confirmation of Loss of Resistance?
2. 2.Is the device a qualitatively effective training tool for educating trainees in how to perform lumbar epidurals?

Conditions

Lumbar Spine Surgery

Keywords

epidural; neuraxial

Outcome Measures

Primary Outcomes (1)

• Real time confirmation of epidural space with loss of resistance technique

  On the post-procedure questionnaire, the anesthesiologist will report about whether the device identified epidural space in agreement with loss of resistance technique. If no, the outcome will be recorded as either a false positive (device signaled epidural space while needle was not in epidural space) or false negative (device did not signal epidural space while needle was in epidural space).

  Post-operation (after the surgery is complete)

Secondary Outcomes (5)

• Clinical (anesthesiologist) opinions on Lumoptik Bright Point Epidural device

  Post-operation (after the surgery is complete)

• Color graphics aid in the identification of needle tips.

  Post-operation (after the surgery is complete)

• The time it takes to insert the epidural needle into the patient's skin.

  From "in OR time" to "time when needle is inserted"

• The time it takes to successfully identify the epidural space.

  From "time when needle is inserted" to "time when epidural space is identified"

• The percentage of Successful Neuraxial Procedures

  Post-operation (after the surgery is complete)

Study Arms (1)

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.

Device: Group 1 - Lumoptik BrightPoint Epidural Device

Interventions

Group 1 - Lumoptik BrightPoint Epidural Device DEVICE

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

Group 1

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to have surgery at the Hospital for Special Surgery that will require a lumbar neuraxial procedure requiring an epidural needle.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

Related Publications (2)

• Lacombe A, Downey K, Ye XY, Carvalho JCA. Long-term complications of unintentional dural puncture during labor epidural analgesia: a case-control study. Reg Anesth Pain Med. 2022 Jun;47(6):364-369. doi: 10.1136/rapm-2021-103266. Epub 2022 Mar 25.

  PMID: 35338103 RESULT

• Eley VA, Abeypala W, Kelley A, Kumta N, Chin A. Recognized and unrecognized dural punctures in 12,981 labor epidurals: an audit of management. J Anesth. 2022 Jun;36(3):399-404. doi: 10.1007/s00540-022-03062-7. Epub 2022 Apr 27.

  PMID: 35474399 RESULT

Study Officials

• Michael Singleton, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pa Thor, PhD

CONTACT

646-797-8535; thorp@hss.edu

Maya Tailor

CONTACT

646-714-6828; tailorm@hss.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: August 31, 2023
• Study Start: September 12, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)