Back to resultsA 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)
Primary Purpose
Chronic Pain
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
EpiFinder
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
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
Sites / Locations
- Rambam Medical CenterRecruiting
- Sourasky Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EpiFinder
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Device Efficacy - Epidural Space Identification
Ability of the physician to identify the epidural space using the EpiFinder. Once the device determines that the needle tip is in the epidural space, this position will then be confirmed by epidurography
Device Performance - Physician satisfaction
physician's overall satisfaction from the device, as measured by a completion of an internal ease of use questionnaire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04047927
Brief 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)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2019 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
November 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Omeq Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EpiFinder
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
EpiFinder
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety - Device Related Serious Adverse Events
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Device Efficacy - Epidural Space Identification
Description
Ability of the physician to identify the epidural space using the EpiFinder. Once the device determines that the needle tip is in the epidural space, this position will then be confirmed by epidurography
Time Frame
Procedure
Title
Device Performance - Physician satisfaction
Description
physician's overall satisfaction from the device, as measured by a completion of an internal ease of use questionnaire.
Time Frame
Procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maya Shick
Phone
972-52-3355442
Email
mayashick@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lior Margalit
Phone
972-54-4315304
Email
lior@omeqmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lior Margalit
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Chair
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
May Hadad
Email
ma_haddad@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Rima Geller, MD
Facility Name
Sourasky Medical Center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hila Greener
Email
hilagre@tlvmc.gov.il
First Name & Middle Initial & Last Name & Degree
Silviu Brill, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Learn more about this trial
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)
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