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)
Unknown statusNot applicableNCT04047927
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- 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)
- Conditions
- Interventions
- Device: EpiFinder
- Sponsor
- Omeq Medical
- Start date
- 2019-12-15
- Primary completion
- 2021-11
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Israel
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04047927