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.
調査の概要
研究の種類
介入
入学 (推定)
100
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Maja Green, PhD, MBA
- 電話番号：858-910-1778
- メール：mgreen@solarisresearchinstitute.com
研究連絡先のバックアップ
- 名前：Michelle Yi, BSC
- 電話番号：760-846-5822
- メール：myi@solarisresearchinstitute.com
研究場所
-
-
California
-
San Diego、California、アメリカ、92111
- Innovative Pain Treatment Solutions
-
主任研究者：
- Krishnan Chakravarthy, MD, PhD
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Temecula、California、アメリカ、92590
- Innovative Pain Treatment Solutions
-
主任研究者：
- Krishnan Chakravarthy, MD, PhD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Conventional LOR Syringe
Standard-of-care loss-of-resistance technique using a conventional syringe during epidural procedures
|
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.
|
|
実験的：EpiFaith™ Syringe
EpiFaith™ syringe used in place of conventional LOR technique.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Measure number of attempts
時間枠：Intra-procedure
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Measure: Number of puncture/needle placement attempts required to achieve successful epidural space access
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Intra-procedure
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Measure false loss-of-resistance
時間枠：Intra-procedure
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Measure: False-positive loss-of-resistance (false LOR) rate, confirmed via epidurography/fluoroscopic contrast pattern when performed per routine care
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Intra-procedure
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Measure device related and procedure-related adverse events
時間枠：Procedure day through approximately 1 week post-procedure
|
Measure: Incidence, nature, and severity of device-related and procedure-related adverse events
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Procedure day through approximately 1 week post-procedure
|
|
Change in pain intensity score on the 11-Point Numeric Rating Scale (NRS)
時間枠：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.
|
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Clinician Usability Score on a 5-Point Likert Agreement Scale
時間枠：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.
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Immediately after completion of the index epidural procedure on Day 0, before participant discharge.
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Procedure Duration From Skin Puncture to Successful Epidural Access
時間枠：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.
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During the index epidural procedure on Day 0.
|
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Procedure success rate
時間枠：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
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During the index epidural procedure on Day 0.
|
|
Contrast-confirmed epidural spread rate
時間枠：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
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During the index epidural procedure on Day 0.
|
|
Total Fluoroscopy time
時間枠：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.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：Maja Green, PhD, MBA、Solaris Research Institute Inc
- 主任研究者：Krishnan Chakravarthy, MD, PhD、Solaris Research Institute Inc
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月28日
一次修了 (推定)
2026年9月27日
研究の完了 (推定)
2026年12月28日
試験登録日
最初に提出
2026年5月24日
QC基準を満たした最初の提出物
2026年6月12日
最初の投稿 (実際)
2026年6月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月17日
QC基準を満たした最後の更新が送信されました
2026年6月12日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- FM-EF-REG-001
- 20261196 (レジストリ識別子：WCG IRB)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
はい
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
慢性の痛みの臨床試験
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Bingol UniversityAtaturk Universityまだ募集していません術前不安 | 恐れ | PAİN
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