A Single Arm, Open-label First In Human Study for Assessing the Safety and Performance of the EpiFinder in Subjects With Clinical Indication for Lumbar Epidural Steroids Injection (ESI)

Study Overview
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Brief Summary
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The EpiFinder device, which is the investigational device in this study, is intended for use in epidural procedures, between a luer syringe and an epidural needle, to give the treating physician a clear indication that the needle tip has entered the epidural space. The objective of this First In Human study is to evaluate the safety and performance of using the EpiFinder to identify the epidural space in subjects with a clinical indication to receive a lumbar Epidural Steroid Injections.

Official Title
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A Single Arm, Open-label First In Human Study for Assessing the Safety and Performance of the EpiFinder in Subjects With Clinical Indication for Lumbar Epidural Steroids Injection (ESI)

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: EpiFinder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 18 years or older Subject with clinical indication for lumbar ESI based on subject's clinical problem (e.g. DDD hernia disc, spinal stenosis) Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed Exclusion Criteria: Subject with marked spinal deformities Previous back surgery Contraindication for epidural injections (e.g. continuous use of anticoagulants, infection, allergic reactions to the injected substances) Subject has known hypersensitivity to contrast media that cannot be pre-medicated Subject with severe obesity (body mass index >35 kg/m2) Subject observed seizure within 7 days prior to study enrollment Subject presenting for emergency Subject has a skin condition (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo) in their lumbar region Subject is pregnant (to be determined by urine pregnancy test) Subject who is currently participating or has participated in an investigational study, within the past 30 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EpiFinder<br>Eligible subjects will be included to this group to receive an epidural injection of steroids to treat their chronic back pain. The investigational device will be used in conjugation to the standard practice of epidural injections, to assist the investigator to identify the epidural space. | Device: EpiFinder<br>* The EpiFinder is a sensing device intended to assist physicians performing placement of epidural needle analgesic and/or anesthesia injection in a safely and accurately manner. The device is a single use sterile device consisting of a probe (Stylet), an actuator (micro DC motor), IR sensor and Controller. The device is integrated to a standard LOR Syringe and an 18G Tuohy needle and enables to simultaneously work with the standard LOR technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Device Related Serious Adverse Events | cumulative incidence of device-related complications and Serious adverse events (AE), observed during the procedure and throughout the follow-up period. Device related adverse events include: dural puncture with or without headache, epidural hematoma, seizures, neurological deficit or relevant device complications. All related and non-related adverse events will be observed on a continuous basis from the baseline through the study completion. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Efficacy - Epidural Space Identification | Ability of the physician to identify the epidural space using the EpiFinder. Once the device determines that the needle tip is in the epidural space, this position will then be confirmed by epidurography | Procedure | 
| Device Performance - Physician satisfaction | physician's overall satisfaction from the device, as measured by a completion of an internal ease of use questionnaire. | Procedure |