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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EpiFinder | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EpiFinder | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maya Shick | Contact | 972-52-3355442 | mayashick@gmail.com | |
| Lior Margalit | Contact | 972-54-4315304 | lior@omeqmedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Lior Margalit | Sponsor GmbH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Medical Center | Recruiting | Haifa | Israel |
All subject data will be anonymized, using only subject number and initials. All source data, such as laboratory results, will be kept on site only and will not be forwarded to the sponsor. All subject personal data will not be published.
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|
physician's overall satisfaction from the device, as measured by a completion of an internal ease of use questionnaire. |
| Procedure |
| Sourasky Medical Center | Recruiting | Tel Aviv | Israel |
|
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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