Clinical Evaluation of the EpiFaith™ Syringe in Epidural Pain Management

Part of paid clinical trials in San Diego, California.

Sponsor
Flat Medical Co., Ltd
Study ID
NCT07654907
Status
Not Yet Recruiting

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Conditions

  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EpiFaith™ Syringe — DEVICE
    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 Syringe — DEVICE
    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.

Study Details

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.

Key Dates

Start date
May 28, 2026
Status verified
Jun 2026
Primary completion
Sep 27, 2026
Completion
Dec 28, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Conventional LOR Syringe
    Standard-of-care loss-of-resistance technique using a conventional syringe during epidural procedures
  • Experimental: EpiFaith™ Syringe
    EpiFaith™ syringe used in place of conventional LOR technique.

Primary Outcome Measure

Measure number of attempts [ Time Frame: Intra-procedure ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Innovative Pain Treatment SolutionsSan DiegoCalifornia92111
Krishnan Chakravarthy, MD, PhD (PRINCIPAL_INVESTIGATOR)
Innovative Pain Treatment SolutionsTemeculaCalifornia92590
Krishnan Chakravarthy, MD, PhD (PRINCIPAL_INVESTIGATOR)

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Innovative Pain Treatment Solutions· San Diego, CAInnovative Pain Treatment Solutions· Temecula, CA

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