An interventional study of EpiFaith™ Syringe and Conventional Loss-of-Resistance Syringe in Chronic Pain, sponsored by Flat Medical Co., Ltd. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Flat Medical Co., Ltd · Not applicable, Interventional, and Other
This study evaluates a new medical device called the EpiFaith™ Syringe, which is designed to help clinicians more accurately identify the epidural space during pain management procedures. The epidural space is a narrow area near the spine where medication is delivered to treat chronic pain conditions. Finding this space correctly is a critical step in procedures such as epidural steroid injections, spinal cord stimulator placement, and minimally invasive lumbar decompression (MILD).
Currently, clinicians locate the epidural space using a method called loss-of-resistance (LOR), which relies on the feel of a syringe plunger as a needle is advanced toward the epidural space. This technique depends on the clinician's experience and touch, and can sometimes result in multiple needle attempts or an incorrect signal that the epidural space has been reached when it has not.
The EpiFaith™ Syringe is designed to provide a clear visual signal, called the Faith Signal, at the moment the epidural space is entered, reducing reliance on touch alone. The device is used with standard epidural needles and does not require additional equipment or significant changes to routine procedure workflow.
This study will enroll 100 adults scheduled for a clinically indicated epidural pain procedure at Innovative Pain Treatment Solutions in Temecula or San Diego, California. Participants will be assigned to have their procedure performed using either the EpiFaith™ Syringe or a standard LOR syringe. The study will compare the number of needle attempts needed to access the epidural space and the rate of false signals between the two methods. Safety and patient-reported pain outcomes will also be collected for approximately one week following the procedure.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Flat Medical Co., Ltd is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Standard-of-care loss-of-resistance technique using a conventional syringe during epidural procedures
Device: Conventional Loss-of-Resistance Syringe
EpiFaith™ syringe used in place of conventional LOR technique.
Device: EpiFaith™ Syringe
The EpiFaith™ Syringe is a sterile, single-use piston syringe designed to assist clinicians in identifying the epidural space during neuraxial procedures. Unlike conventional loss-of-resistance syringes that rely solely on tactile feedback, the EpiFaith™ incorporates a spring-loaded piston mechanism that produces an objective visual indicator, the "Faith Signal," at the moment resistance decreases consistent with epidural space entry. The device is compatible with standard epidural needles and integrates into routine procedural workflow without significant modification.
Standard saline loss-of-resistance technique using a conventional epidural syringe. The clinician applies intermittent or continuous pressure to the syringe plunger while advancing the epidural needle, interpreting a sudden reduction in resistance as entry into the epidural space. No investigational device is used in this arm.
Measure number of attempts
Measure: Number of puncture/needle placement attempts required to achieve successful epidural space access
Time frame: Intra-procedure
Measure false loss-of-resistance
Measure: False-positive loss-of-resistance (false LOR) rate, confirmed via epidurography/fluoroscopic contrast pattern when performed per routine care
Time frame: Intra-procedure
Measure device related and procedure-related adverse events
Measure: Incidence, nature, and severity of device-related and procedure-related adverse events
Time frame: Procedure day through approximately 1 week post-procedure
Change in pain intensity score on the 11-Point Numeric Rating Scale (NRS)
Pain intensity will be assessed using the 11-point Numeric Rating Scale for pain, scored from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Change from baseline will be calculated at each post-procedure follow-up time point. Negative change values indicate improvement, reflecting lower pain intensity compared with baseline.
Time frame: Baseline before the procedure on Day 0 and approximately 3 hours, 24 hours, 48 hours, 72 hours, and 7 days after the procedure.
Clinician Usability Score on a 5-Point Likert Agreement Scale
Clinician usability and workflow integration will be assessed immediately after the procedure using a structured post-procedure questionnaire. The questionnaire evaluates ease of setup and preparation, clarity of the visual indicator, support for stable and controlled needle advancement, confidence in identifying the epidural space, integration into standard workflow, reduction in uncertainty compared with conventional loss-of-resistance technique, overall satisfaction, and willingness to use the device again for similar procedures. Each item is scored on a 5-point Likert agreement scale from 1 to 5, where 1 indicates strongly disagree, 3 indicates neutral, and 5 indicates strongly agree. Higher scores indicate better clinician-perceived usability, satisfaction, and workflow integration.
Time frame: Immediately after completion of the index epidural procedure on Day 0, before participant discharge.
Procedure Duration From Skin Puncture to Successful Epidural Access
Procedure duration will be measured as the time from initial epidural needle skin puncture to successful epidural space access during the index procedure. Duration will be recorded in minutes based on the procedure record or other prespecified time documentation. Lower values indicate shorter time to epidural access.
Time frame: During the index epidural procedure on Day 0.
Procedure success rate
Procedure success rate will be defined as the proportion of participants in whom successful epidural access is achieved and the intended epidural procedure is completed as planned without procedure abortion or conversion to an alternative non-study approach. Higher percentages indicate greater procedural success. Unit of measure: Percentage of participants
Time frame: During the index epidural procedure on Day 0.
Contrast-confirmed epidural spread rate
Contrast-confirmed epidural spread rate will be defined as the proportion of participants with documented epidural contrast spread among participants in whom contrast injection is performed as part of routine clinical care. Participants in whom contrast is not used per routine care will not be included in the denominator for this outcome measure. Higher percentages indicate a greater rate of imaging-confirmed epidural spread. Unit of measure: Percentage of participants with contrast use
Time frame: During the index epidural procedure on Day 0.
Total Fluoroscopy time
Total fluoroscopy time will be recorded for participants in whom fluoroscopy is used as part of routine clinical care during the index epidural procedure. Fluoroscopy time will be measured in seconds based on the procedure record or fluoroscopy system output. Lower values indicate shorter fluoroscopy exposure time.
Time frame: During the index epidural procedure on Day 0.
Plan to share: No
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Flat Medical Co., Ltd