Chronic Lower Limb Pain
Conditions
Keywords
Electrode, Injectable Electrode, Injectrode, Medical Device Safety
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.
Interventions
DEVICENeuronoff BASMATI Injectrode
The 28 day temporary placement of a Basmati Injectrode does not result in unexpected levels of inflammation or encapsulation.
Sponsors
Ohio Pain Clinic
Neuronoff, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety - Number of Participants With Device-Related Adverse Events & Histological Analysis | 28 days | Primary measures of device safety included verification of the absence of unexpected inflammation and minimization of excessive encapsulation around the Injectrode as verified by cell staining and pathohistological analysis. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Neuronoff BASMATI Injectrode See Inclusion/Exclusion Criteria | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Neuronoff BASMATI Injectrode | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 1 Participants | — |
| Age, Categorical Between 18 and 65 years | 9 Participants | — |
| Age, Continuous | 47.3 years STANDARD_DEVIATION 12.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 10 participants | — |
| Sex: Female, Male Female | 6 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Safety - Number of Participants With Device-Related Adverse Events & Histological Analysis
Primary measures of device safety included verification of the absence of unexpected inflammation and minimization of excessive encapsulation around the Injectrode as verified by cell staining and pathohistological analysis.
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Neuronoff BASMATI Injectrode | Safety - Number of Participants With Device-Related Adverse Events & Histological Analysis | 0 Participants |