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Clinical Evaluation of the EpiFaith™ Syringe in Epidural Pain Management

12 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

100

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Stany Zjednoczone
    • California
      • San Diego, California, Stany Zjednoczone, 92111
        • Innovative Pain Treatment Solutions
        • Główny śledczy:
          • Krishnan Chakravarthy, MD, PhD
      • Temecula, California, Stany Zjednoczone, 92590
        • Innovative Pain Treatment Solutions
        • Główny śledczy:
          • Krishnan Chakravarthy, MD, PhD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Conventional LOR Syringe
Standard-of-care loss-of-resistance technique using a conventional syringe during epidural procedures
Urządzenie: 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.
Eksperymentalny: EpiFaith™ Syringe
EpiFaith™ syringe used in place of conventional LOR technique.
Urządzenie: 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.

Co mierzy badanie?

Podstawowe miary wyniku

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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Measure device related and procedure-related adverse events
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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.

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Procedure Duration From Skin Puncture to Successful Epidural Access
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Flat Medical Co., Ltd

Śledczy

  • Dyrektor Studium: Maja Green, PhD, MBA, Solaris Research Institute Inc
  • Główny śledczy: Krishnan Chakravarthy, MD, PhD, Solaris Research Institute Inc

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

28 maja 2026

Zakończenie podstawowe (Szacowany)

27 września 2026

Ukończenie studiów (Szacowany)

28 grudnia 2026

Daty rejestracji na studia

Pierwszy przesłany

24 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

17 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

17 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • FM-EF-REG-001
  • 20261196 (Identyfikator rejestru: WCG IRB)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Tak

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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