Clinical Evaluation of the EpiFaith™ Syringe in Epidural Pain Management
ConditionChronic Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFlat Medical Co., Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older at the time of informed consent.
Scheduled to undergo a clinically indicated interventional pain management procedure as part of routine clinical care at the study site.
Planned procedure requires epidural space localization using the loss-of-resistance technique and is compatible with use of either a conventional loss-of-resistance syringe or the EpiFaith™ syringe, in the judgment of the treating clinician.
Eligible procedure types include cervical, thoracic, lumbar, or caudal epidural procedures; minimally invasive lumbar decompression (MILD) procedures when epidural access or localization is required; and spinal cord stimulation (SCS) trial epidural access procedures.
Disqualifiers
Inability to provide written informed consent independently, including adults who require consent by a legally authorized representative.
Known contraindication to the planned epidural procedure, including active infection at the puncture site, uncontrolled coagulopathy, or anticoagulant or antiplatelet status that precludes the planned procedure in the judgment of the treating clinician.
Known hypersensitivity or contraindication to any standard-of-care medication, contrast agent, or procedural material required for the planned epidural procedure, where such contraindication precludes the procedure.
Participation in another interventional clinical trial that, in the investigator's judgment, would confound interpretation of study endpoints.
Trial design
Design model
Parallel
Treatments tested in this trial
EpiFaith™ Syringe
DeviceThe 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.
Conventional Loss-of-Resistance Syringe
DeviceStandard 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Conventional LOR SyringeActive comparator 1 intervention
Group B: EpiFaith™ SyringeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Measure number of attempts
Measure: Number of puncture/needle placement attempts required to achieve successful epidural space access
Time frame
Intra-procedure2
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-procedureSecondary outcomes
1
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-procedure2
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.3
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.Other outcomes
1
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 0.2
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 0.3
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 0.4
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.Sponsors and contacts
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Source ClinicalTrials.gov
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