Status:
COMPLETED
Basic Assessment of Safety and Minimally Invasive Stimulation Via Injectrode
Lead Sponsor:
Neuronoff, Inc
Collaborating Sponsors:
Ohio Pain Clinic
Conditions:
Chronic Lower Limb Pain
Eligibility:
All Genders
18+ years
Phase:
NA
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 cur...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04672096
Start Date
December 4 2020
End Date
May 21 2021
Last Update
April 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ohio Pain Clinic
Dayton, Ohio, United States, 45458