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NCT06020508 · ClinicalTrials.gov registry record
Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement
A clinical trial of Lumbar Spine Surgery, sponsored by Hospital for Special Surgery, New York.
- Recruiting
- Registry status
- 36
- Enrollment target
- 1
- Study location
NCT06020508: Recruiting study of Lumbar Spine Surgery, sponsored by Hospital for Special Surgery, New York.
NCT06020508 is a study of Lumbar Spine Surgery that is actively recruiting participants, run by Hospital for Special Surgery, New York. The registered enrollment target is 36 participants, below the 201-participant average among 3 other Lumbar Spine Surgery trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06020508, a study of Lumbar Spine Surgery, is actively recruiting participants, sponsored by Hospital for Special Surgery, New York.
- RECRUITING
- Registry status
- 36 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- DEVICE Group 1 - Lumoptik BrightPoint Epidural Device
Study Locations (1)
New York
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2023-09-12 |
| Est. Completion | 2026-07 |
What NCT06020508 shows while recruiting
NCT06020508 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 201-participant average among 3 other Lumbar Spine Surgery trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Lumbar Spine Surgery appearing as the primary indexed condition, and to 1 intervention - of which Group 1 - Lumoptik BrightPoint Epidural Device is the first listed.
NCT06020508 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06020508 about?
NCT06020508 is a clinical study titled "Lumoptik BRIGHTPOINT Reflectometer Device for 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: 1. Is the device a qualitatively effective...
What is the current status of trial NCT06020508?
This trial is currently recruiting. The enrollment target is 36 participants. The study started on 2023-09-12. Estimated completion is 2026-07.
What conditions does trial NCT06020508 study?
This clinical trial studies the following conditions: Lumbar Spine Surgery.
What interventions are being tested in trial NCT06020508?
The interventions under investigation include: Group 1 - Lumoptik BrightPoint Epidural Device (DEVICE).
Who is sponsoring clinical trial NCT06020508?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06020508 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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