Basic Assessment of Safety and Minimally Invasive Stimulation Via Injectrode (BASMATI)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Lower Limb Pain
• Intervention / Treatment: Device: Neuronoff BASMATI Injectrode

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Dayton, Ohio, United States, 45458
      • Ohio Pain Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days

Collaborators and Investigators

• Sponsor: Neuronoff, Inc
• Collaborators: Ohio Pain Clinic
• Investigators: Principal Investigator: Amol Soin, MD, Ohio Pain Clinic

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2020
• Primary Completion (Actual): May 21, 2021
• Study Completion (Actual): May 21, 2021

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Estimated): April 19, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Electrode; Injectable Electrode; Injectrode; Medical Device Safety
• Other Study ID Numbers: NCP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No