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Clinical Evaluation of the EpiFaith™ Syringe in Epidural Pain Management

2026年6月12日 更新者：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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • California
      • San Diego、California、美国、92111
        • Innovative Pain Treatment Solutions
        • 首席研究员：
          • Krishnan Chakravarthy, MD, PhD
      • Temecula、California、美国、92590
        • Innovative Pain Treatment Solutions
        • 首席研究员：
          • Krishnan Chakravarthy, MD, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Conventional LOR Syringe
Standard-of-care loss-of-resistance technique using a conventional syringe during epidural procedures
设备：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.
实验性的：EpiFaith™ Syringe
EpiFaith™ syringe used in place of conventional LOR technique.
设备：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Measure number of attempts
大体时间：Intra-procedure
Measure: Number of puncture/needle placement attempts required to achieve successful epidural space access
Intra-procedure
Measure false loss-of-resistance
大体时间：Intra-procedure
Measure: False-positive loss-of-resistance (false LOR) rate, confirmed via epidurography/fluoroscopic contrast pattern when performed per routine care
Intra-procedure

次要结果测量

结果测量
措施说明
大体时间
Measure device related and procedure-related adverse events
大体时间：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)
大体时间：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
大体时间：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.

其他结果措施

结果测量
措施说明
大体时间
Procedure Duration From Skin Puncture to Successful Epidural Access
大体时间：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
大体时间：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
大体时间：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
大体时间：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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Flat Medical Co., Ltd

调查人员

  • 研究主任：Maja Green, PhD, MBA、Solaris Research Institute Inc
  • 首席研究员：Krishnan Chakravarthy, MD, PhD、Solaris Research Institute Inc

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月28日

初级完成 (估计的)

2026年9月27日

研究完成 (估计的)

2026年12月28日

研究注册日期

首次提交

2026年5月24日

首先提交符合 QC 标准的

2026年6月12日

首次发布 (实际的)

2026年6月17日

研究记录更新

最后更新发布 (实际的)

2026年6月17日

上次提交的符合 QC 标准的更新

2026年6月12日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • FM-EF-REG-001
  • 20261196 (注册表标识符：WCG IRB)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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