NCT06020508 Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement
| NCT ID | NCT06020508 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital for Special Surgery, New York |
| Condition | Lumbar Spine Surgery |
| Study Type | OBSERVATIONAL |
| Enrollment | 36 participants |
| Start Date | 2023-09-12 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 36 participants in total. It began in 2023-09-12 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Michael Singleton, MD
PRINCIPAL INVESTIGATOR
Hospital for Special Surgery, New York
Frequently Asked Questions
Who can join the NCT06020508 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Lumbar Spine Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06020508 currently recruiting?
Yes, NCT06020508 is actively recruiting participants. Contact the research team at thorp@hss.edu for enrollment information.
Where is the NCT06020508 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06020508 clinical trial?
NCT06020508 is sponsored by Hospital for Special Surgery, New York. The principal investigator is Michael Singleton, MD at Hospital for Special Surgery, New York. The trial plans to enroll 36 participants.