N/A
N=10
Basic Assessment of Safety and Minimally Invasive Stimulation Via Injectrode
Chronic Lower Limb Pain
Bottom Line
View on ClinicalTrials.gov: NCT04672096 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Safety - Number of Participants With Device-Related Adverse Events & Histological Analysis — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Neuronoff BASMATI Injectrode (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Neuronoff, Inc
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety - Number of Participants With Device-Related Adverse Events & Histological Analysis |
— | — |
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.
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).
Data sourced from ClinicalTrials.gov (NCT04672096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.