Clinical trial NCT04672096: Basic Assessment of Safety and Minimally Invasive Stimulation Via Injectrode
Official title: Basic Assessment of Safety and Minimally Invasive Stimulation Via Injectrode
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Lower Limb Pain
Keywords: Electrode
Injectable Electrode
Injectrode
Medical Device Safety
Lead sponsor: Neuronoff, Inc
Sponsor class: INDUSTRY
Collaborators: name: Ohio Pain Clinic
First posted: 2020-12-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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: This was a prospective, single-center, single-arm, non-randomized study design. A sample of 10 study participants were enrolled into the study, and provided with the placement of a Basmati Injectrode insert with a maximal placement duration of up to 28 days. Subjects who were selected to participate in the trial were healthy volunteers adults with ages 18 years and older without any preexisting condition indicated for treatment. Each subject was followed during the trial period of approximately 45+/-2 days.

Eligibility criteria: 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).

Primary outcomes:
measure: Safety - Number of Participants With Device-Related Adverse Events & Histological Analysis
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dayton
country: United States
facility: Ohio Pain Clinic
state: Ohio
Study officials:
affiliation: Ohio Pain Clinic
name: Amol Soin, MD
role: PRINCIPAL_INVESTIGATOR
References: