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)

Not Applicable

• Conditions: Chronic Pain
• Interventions: Device: EpiFinder

• Registration Number: NCT04047927
• Lead Sponsor: Omeq Medical

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-01
• Study First Submitted QC: 2019-08-06
• Study First Posted: 2019-08-07
• Study Start: 2019-12-15
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-11
• Last Update Posted: 2021-03-16
• Primary Completion: 2021-11
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EpiFinder	EpiFinder	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.

Primary Outcome Measures

Name	Time	Method
Safety - Device Related Serious Adverse Events	14 days	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.

Secondary Outcome Measures

Name	Time	Method
Device Performance - Physician satisfaction	Procedure	physician's overall satisfaction from the device, as measured by a completion of an internal ease of use questionnaire.
Device Efficacy - Epidural Space Identification	Procedure	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

Trial Locations

Locations (2)

Rambam Medical Center; 🇮🇱 Haifa, Israel

Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel