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)
1 other identifier
interventional
15
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable chronic-pain
Started Dec 2019
Typical duration for not_applicable chronic-pain
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2019
CompletedFirst Posted
Study publicly available on registry
August 7, 2019
CompletedStudy Start
First participant enrolled
December 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedMarch 16, 2021
March 1, 2021
1.9 years
August 1, 2019
March 11, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Device Efficacy - Epidural Space Identification
Procedure
Device Performance - Physician satisfaction
Procedure
Study Arms (1)
EpiFinder
EXPERIMENTALEligible 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Omeq Medicallead
Study Sites (2)
Rambam Medical Center
Haifa, Israel
Sourasky Medical Center
Tel Aviv, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lior Margalit
Sponsor GmbH
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2019
First Posted
August 7, 2019
Study Start
December 15, 2019
Primary Completion
November 1, 2021
Study Completion
November 1, 2021
Last Updated
March 16, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share
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.