Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement
NCT ID: NCT06020508
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
36 participants
OBSERVATIONAL
2023-09-12
2026-07-31
Brief Summary
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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.
Detailed Description
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The BrightPoint Epidural device is the first system that utilizes multispectral reflectometry in order to identify the epidural space. This technology has the theoretical benefit over pressure-based systems of being able to identify and differentiate between different issue types (muscle, ligament, bone) as the needle is advanced towards the epidural space. Lumoptik, the company behind the BrightPoint Epidural device, is an early-stage startup based in Cleveland, Ohio. The main questions this trial 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?
This trial is being conducted to improve our current standard of care in neuraxial placement of loss-of-resistance. While the loss of resistance technique is tried and true, especially in experienced hands, complications such as dural punctures, misplaced epidurals, patchy epidurals, neurologic injuries, and intravascular catheters can occur even in experienced hands. All of which can cause significant patient morbidity and costs to the healthcare system, and as is shown in the Lacombe attached, the effects of dural puncture can be long lived for the patient. There can also be a steep learning curve when learning the technique, with the frequency of inadvertent dural punctures significantly higher in the early stages of learning the procedure. Therefore, we as a specialty are obligated to evaluate potential improvements to our current way of practice to reduce the burden to our patients from the complications of our interventions.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Age 18-99
Exclusion Criteria
* 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
18 Years
99 Years
ALL
Yes
Sponsors
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Hospital for Special Surgery, New York
OTHER
Responsible Party
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Principal Investigators
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Michael Singleton, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital for Special Surgery, New York
Locations
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Hospital for Special Surgery
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
van der Hek H, Plomp HN. Occupational stress management programmes: a practical overview of published effect studies. Occup Med (Lond). 1997 Apr;47(3):133-41. doi: 10.1093/occmed/47.3.133.
Other Identifiers
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2023-0074
Identifier Type: -
Identifier Source: org_study_id