Lumbar Spine SurgeryNCT06020508
Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement
An observational study of Lumbar Spine Surgery, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Spine Surgery
- What is being tested?
- Group 1 - Lumoptik BrightPoint Epidural Device
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2023to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled to have surgery at the Hospital for Special Surgery that will require a lumbar neuraxial procedure requiring an epidural needle.
Who may be able to join
- Any patient undergoing a lumbar neuraxial procedure requiring epidural needle
- Age 18-99
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
Justas Lauzadis, PhD, 212-774-2946, lauzadisj@hss.edu
Pa Thor, PhD, 646-797-8535, thorp@hss.edu
About this study
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
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:
- Is the device a qualitatively effective secondary confirmation of Loss of Resistance?
- 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.
Read the detailed description
There have been few improvements to the LOR technique from a device standpoint in recent years, and those that options do exist have not achieved widespread clinical use. The devices that do exist are variations on pressure sensors, some automate the "resistance" by placing various systems in place to apply a pressure to the plunger so that it will inject when the epidural space is accessed without the practitioner doing it themselves. This concept is represented by devices such as the Epimatic syringe from Vygon. Others improve on this concept by monitoring the pressure required to inject a set volume of fluid, thus being able to differentiate between true and false losses, as during false losses the pressure will increase as more fluid is injected. This system is represented by the CompuFlo Device by Milestone Scientific.
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:
- Is the device a qualitatively effective secondary confirmation of Loss of Resistance?
- 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
- Lumbar Spine Surgery
- Being tested
- Group 1 - Lumoptik BrightPoint Epidural Device
- Keywords
- epidural, neuraxial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 - Lumoptik BrightPoint Epidural DeviceDevice
Participants will undergo a neuraxial procedure to measure loss of resistance with saline in conjunction with the Lumoptik BrightPoint Epidural Device.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Group 1 - Lumoptik BrightPoint Epidural Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Post-operation (after the surgery is complete)
Secondary outcomes (5)
Clinical (anesthesiologist) opinions on Lumoptik Bright Point Epidural device
On the post-procedure questionnaire, the anesthesiologist will give their opinion about the device following their use of the study device.
Measured: Post-operation (after the surgery is complete)
Color graphics aid in the identification of needle tips.
On the post-procedure questionnaire, the proceduralist will give a yes or no answer to the prompt to the question "Did the Bright Point Epidural color graphic improve your understanding of where your needle tip is or what tissue it is in?"
Measured: Post-operation (after the surgery is complete)
The time it takes to insert the epidural needle into the patient's skin.
The time between when the patient entered the operating room and when the epidural needle was inserted into the patient's skin.
Measured: From "in OR time" to "time when needle is inserted"
The time it takes to successfully identify the epidural space.
The time between inserting an epidural needle into the skin and successfully identifying the epidural space.
Measured: From "time when needle is inserted" to "time when epidural space is identified"
The percentage of Successful Neuraxial Procedures
The percentage of successful neuraxial procedures, calculated by dividing "the number successful neuraxial procedures placed without assistance or complication by the number of attempted neuraxial procedures"
Measured: Post-operation (after the surgery is complete)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start12 Sep 2023
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spine SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Singleton, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020508
- Sponsor's protocol ID
- 2023-0074
- Status last verified
- Nov 2025
- First submitted
- 28 Aug 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 35338103Eley 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.
PubMed 35474399
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06020508
- Acronym / sponsor ID
- 2023-0074
- Conditions
- Lumbar Spine Surgery
- Keywords
- epidural, neuraxial
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is the device a qualitatively effective secondary confirmation of Loss of Resistance?
- 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
There have been few improvements to the LOR technique from a device standpoint in recent years, and those that options do exist have not achieved widespread clinical use. The devices that do exist are variations on pressure sensors, some automate the "resistance" by placing various systems in place to apply a pressure to the plunger so that it will inject when the epidural space is accessed without the practitioner doing it themselves. This concept is represented by devices such as the Epimatic syringe from Vygon. Others improve on this concept by monitoring the pressure required to inject a set volume of fluid, thus being able to differentiate between true and false losses, as during false losses the pressure will increase as more fluid is injected. This system is represented by the CompuFlo Device by Milestone Scientific.
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:
- Is the device a qualitatively effective secondary confirmation of Loss of Resistance?
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: Group 1 - Lumoptik BrightPoint Epidural DeviceAttending 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to have surgery at the Hospital for Special Surgery that will require a lumbar neuraxial procedure requiring an epidural needle.
Key inclusion criteria (2 listed)
- Any patient undergoing a lumbar neuraxial procedure requiring epidural needle
- Age 18-99
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1 - Lumoptik BrightPoint Epidural DeviceParticipants will undergo a neuraxial procedure to measure loss of resistance with saline in conjunction with the Lumoptik BrightPoint Epidural Device. | Device | Group 1 |
Primary outcome
Real time confirmation of epidural space with loss of resistance technique
Time frame: Post-operation (after the surgery is complete)
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).
5 secondary outcomes
Clinical (anesthesiologist) opinions on Lumoptik Bright Point Epidural device
Time frame: Post-operation (after the surgery is complete)
Color graphics aid in the identification of needle tips.
Time frame: Post-operation (after the surgery is complete)
The time it takes to insert the epidural needle into the patient's skin.
Time frame: From "in OR time" to "time when needle is inserted"
The time it takes to successfully identify the epidural space.
Time frame: From "time when needle is inserted" to "time when epidural space is identified"
The percentage of Successful Neuraxial Procedures
Time frame: Post-operation (after the surgery is complete)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Results publication: PubMed 35338103Lacombe 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.
- Results publication: PubMed 35474399Eley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Singleton, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spine Surgery, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pa Thor, PhD (646-797-8535, thorp@hss.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real time confirmation of epidural space with loss of resistance technique (time frame: Post-operation (after the surgery is complete)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06020508, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.