Using a new device to improve lumbar epidural placement
Pilot Study for Human Clinical Trial to Evaluate the BRIGHTPOINT Reflectometer Device as Secondary Confirmation to Loss of Resistance in Lumbar Epidural Placement
This study is testing a new device that helps doctors find the right spot for epidurals during back procedures to see if it works better than traditional methods and can help train new doctors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Hospital for Special Surgery, New York Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06020508 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the BrightPoint Epidural device, which employs multispectral reflectometry to assist in locating the epidural space during lumbar neuraxial procedures. The study aims to determine if this device can serve as an effective secondary confirmation of the Loss of Resistance technique and if it can be utilized as a training tool for medical trainees. Participants will undergo a lumbar neuraxial procedure where the attending anesthesiologist will assess the device's effectiveness in confirming access to the epidural space. The trial seeks to address the need for advancements in epidural placement technology.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18-99 who are undergoing a lumbar neuraxial procedure requiring an epidural needle.
Not a fit: Patients with previous lumbar spine surgery or known spinal abnormalities that could interfere with needle advancement may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could enhance the accuracy and safety of lumbar epidural placements, potentially reducing complications and improving patient outcomes.
How similar studies have performed: While there have been various devices developed for epidural placement, the use of multispectral reflectometry in this context is novel and has not been widely tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Hospital for Special Surgery — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Michael Singleton, MD — Hospital for Special Surgery, New York
- Study coordinator: Pa Thor, PhD
- Email: thorp@hss.edu
- Phone: 646-797-8535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.