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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)

NCT04047927 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-03-16

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Omeq Medical

    lead INDUSTRY

Principal Investigators

  • Lior Margalit · Sponsor GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-15
Primary Completion
2021-11-30
Completion
2021-11-30

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04047927 on ClinicalTrials.gov