Basic Assessment of Safety and Minimally Invasive Stimulation Via Injectrode

Study Overview
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Brief Summary
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The objectives of this non-significant risk (NSR) study are to evaluate the safety of the short term placement of the Basmati Injectrode for up to 28 days and the efficacy of conducting electrical current to stimulate subcutaneous nerves on the explant date just prior to explant.

Detailed Description
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The proposed study is a prospective, single-center, single-arm, non-randomized design. Up to 10 study subjects will be provided with the placement of an Injectrode insert. The maximal placement duration will be 28 days. Subjects selected to participate in the trial are healthy without any preexisting condition indicated to be treated. Each subject will be followed during the trial period of approximately 50 days, including the time for screening and post-explant follow-up. The study will end when the last subject has completed the trial period and exited. After exit from the clinical study, subjects will continue to be followed by their physician per standard of care. All device and procedure-related adverse events (AEs) and unanticipated problems (UPs) will be collected and reported per the study protocol.

Official Title
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Basic Assessment of Safety and Minimally Invasive Stimulation Via Injectrode

Conditions
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Safety Issues

Intervention / Treatment
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* Device: Neuronoff BASMATI Injectrode


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) and understand the study requirements. Be 18 years of age or older when written informed consent is obtained. Be in good physical and mental health as assessed by a general practitioner. Be able to tolerate electrical stimulation (TENS). Be willing and able to understand and comply with all study-related procedures during the course of the study. Exclusion Criteria: Have a cognitive impairment or exhibit any characteristic that would limit the study candidate's ability to completely understand and sign a valid, IRB-approved informed consent form. Have a positive pregnancy test (conducted during enrollment). Have a positive Allergic reactivity to Gold skin test (conducted during enrollment). Show symptoms indicative for Covid19 as assessed during enrollment. Have a skin condition at the planned surgical location. Have a blood coagulation disorder or other indication with the potential to impact the study biocompatibility data in unpredictable ways. Have a medical condition that is a contraindication for minimally invasive surgery. Be implanted with a cardiac defibrillator or pump. Have a history of cardiac arrhythmia with hemodynamic instability Be implanted with a neurostimulator. Have any active electrical implant of any other kind. Have metal implants (particularly in hip). Have active infection. Have allodynia. Take regular use of antiplatelet medications (e.g. aspirin, ticlopidine (Ticlid), clopidogrel (Plavix), tirofiban (Aggrastat) or eptifibatide (Integrilin)). Have untreated drug habituation or dependence. Have uncontrolled seizures (averaging > 2 seizures per month). Currently require, or be likely to require, diathermy and/or MRI during study duration. Have a history of adverse reactions to local anesthetics (e.g. lidocaine).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuronoff BASMATI Injectrode<br>Subjects will be provided with the placement of an Injectrode insert. The maximal placement duration will be 28 days. | Device: Neuronoff BASMATI Injectrode<br>* The 28 day temporary placement of a Basmati Injectrode does not result in unexpected levels of inflammation or encapsulation.<br>* Other names: BASMATI Injectrode;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - No Adverse Events | Primary measures of safety will be the absence of adverse events at any of the study visits or in follow-up. | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrode, Injectable Electrode, Injectrode, Medical Device Safety