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)

Chronic Pain Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04047927
• Other study ID #: PCL-100-01
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2019
• Est. completion date: November 2021

Study information

• Verified date: March 2021
• Source: Omeq Medical
• Contact: Maya Shick
• Phone: 972-52-3355442
• Email: mayashick[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: November 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• EpiFinder
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.

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa
Israel	Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Omeq Medical

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Procedure
Secondary	Device Performance - Physician satisfaction	physician's overall satisfaction from the device, as measured by a completion of an internal ease of use questionnaire.	Procedure