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Clinical Evaluation of the EpiFaith™ Syringe in Epidural Pain Management

12 juni 2026 bijgewerkt door: Flat Medical Co., Ltd

Clinical Evaluation of the EpiFaith™ Syringe in Epidural Pain Management: A Prospective, Open-Label, Non-Randomized Comparative Study Versus Conventional Loss-of-Resistance Technique

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • California
      • San Diego, California, Verenigde Staten, 92111
        • Innovative Pain Treatment Solutions
        • Hoofdonderzoeker:
          • Krishnan Chakravarthy, MD, PhD
      • Temecula, California, Verenigde Staten, 92590
        • Innovative Pain Treatment Solutions
        • Hoofdonderzoeker:
          • Krishnan Chakravarthy, MD, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Conventional LOR Syringe
Standard-of-care loss-of-resistance technique using a conventional syringe during epidural procedures
Apparaat: Conventional Loss-of-Resistance Syringe
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.
Experimenteel: EpiFaith™ Syringe
EpiFaith™ syringe used in place of conventional LOR technique.
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Measure number of attempts
Tijdsspanne: Intra-procedure
Measure: Number of puncture/needle placement attempts required to achieve successful epidural space access
Intra-procedure
Measure false loss-of-resistance
Tijdsspanne: Intra-procedure
Measure: False-positive loss-of-resistance (false LOR) rate, confirmed via epidurography/fluoroscopic contrast pattern when performed per routine care
Intra-procedure

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Measure device related and procedure-related adverse events
Tijdsspanne: Procedure day through approximately 1 week post-procedure
Measure: Incidence, nature, and severity of device-related and procedure-related adverse events
Procedure day through approximately 1 week post-procedure
Change in pain intensity score on the 11-Point Numeric Rating Scale (NRS)
Tijdsspanne: Baseline before the procedure on Day 0 and approximately 3 hours, 24 hours, 48 hours, 72 hours, and 7 days after the procedure.
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.
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
Tijdsspanne: Immediately after completion of the index epidural procedure on Day 0, before participant discharge.
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.
Immediately after completion of the index epidural procedure on Day 0, before participant discharge.

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Procedure Duration From Skin Puncture to Successful Epidural Access
Tijdsspanne: During the index epidural procedure on Day 0.
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.
During the index epidural procedure on Day 0.
Procedure success rate
Tijdsspanne: During the index epidural procedure on Day 0.
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
During the index epidural procedure on Day 0.
Contrast-confirmed epidural spread rate
Tijdsspanne: During the index epidural procedure on Day 0.
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
During the index epidural procedure on Day 0.
Total Fluoroscopy time
Tijdsspanne: During the index epidural procedure on Day 0.
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.
During the index epidural procedure on Day 0.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Flat Medical Co., Ltd

Onderzoekers

  • Studie directeur: Maja Green, PhD, MBA, Solaris Research Institute Inc
  • Hoofdonderzoeker: Krishnan Chakravarthy, MD, PhD, Solaris Research Institute Inc

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

28 mei 2026

Primaire voltooiing (Geschat)

27 september 2026

Studie voltooiing (Geschat)

28 december 2026

Studieregistratiedata

Eerst ingediend

24 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

12 juni 2026

Eerst geplaatst (Werkelijk)

17 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

12 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • FM-EF-REG-001
  • 20261196 (Register-ID: WCG IRB)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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