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)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Device: EpiFinder

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maya Shick; Phone Number: 972-52-3355442; Email: mayashick@gmail.com
• Study Contact Backup: Name: Lior Margalit; Phone Number: 972-54-4315304; Email: lior@omeqmedical.com

Study Locations

• Israel
  • Haifa, Israel
    • Recruiting
    • Rambam Medical Center
    • Contact: May Hadad; Email: ma_haddad@rambam.health.gov.il
    • Principal Investigator: Rima Geller, MD
  • Tel Aviv, Israel
    • Recruiting
    • Sourasky Medical Center
    • Contact: Hila Greener; Email: hilagre@tlvmc.gov.il
    • Principal Investigator: Silviu Brill, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: EpiFinder; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Omeq Medical
• Investigators: Study Chair: Lior Margalit, Sponsor GmbH

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2019
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (Actual): August 7, 2019

Study Record Updates

• Last Update Posted (Actual): March 16, 2021
• Last Update Submitted That Met QC Criteria: March 11, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: PCL-100-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No