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)

Omeq Medical

Status: Unknown

Conditions: Chronic Pain

Treatments: Device: EpiFinder

Study type: Interventional

Funder types: Industry

Identifiers

NCT04047927

PCL-100-01

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

EpiFinder

Experimental group

Description:

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.

Treatment:

Device: EpiFinder