Status:
UNKNOWN
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)
Lead Sponsor:
Omeq Medical
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
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 cle...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04047927
Start Date
December 15 2019
End Date
November 1 2021
Last Update
March 16 2021
Active Locations (2)
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1
Rambam Medical Center
Haifa, Israel
2
Sourasky Medical Center
Tel Aviv, Israel