Clinical Evaluation of the EpiFaith™ Syringe in Epidural Pain Management

N/ANot Yet RecruitingNCT07654907

Flat Medical Co., Ltd100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

100

Interventions

EpiFaith™ SyringeDEVICE

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.

Conventional Loss-of-Resistance SyringeDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. * Able and willing to provide written informed consent before any study-specific data collection. * Able and willing to comply with post-procedure follow-up assessments through approximately 1 week after the procedure, including telephone or telehealth follow-up when applicable. * For participants receiving anticoagulant or antiplatelet therapy, the treating clinician must determine that the participant can safely undergo the planned epidural procedure according to standard institutional practice and applicable neuraxial anticoagulation guidance. Exclusion Criteria: * 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. * Any medical, anatomic, procedural, or clinical condition that, in the investigator's judgment, would make study participation unsafe or not in the participant's best interest. * Pregnancy, unless the epidural procedure is clinically indicated and permitted under the enrolling site's standard clinical practice and IRB-approved procedures. * Unwillingness or inability to complete required study assessments through approximately 1 week after the procedure.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.