Basic Assessment of Safety and Minimally Invasive Stimulation Via Injectrode

Chronic Lower Limb Pain Clinical Trial

— BASMATI  

Official title:

Basic Assessment of Safety and Minimally Invasive Stimulation Via Injectrode

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04672096
• Other study ID #: NCP-01
• Status: Completed
• Phase: N/A
• Start date: December 4, 2020
• Est. completion date: May 21, 2021

Study information

• Verified date: November 2023
• Source: Neuronoff, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 21, 2021
• Est. primary completion date: May 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Lower Limb Pain

Intervention

Device:
• Neuronoff BASMATI Injectrode
The 28 day temporary placement of a Basmati Injectrode does not result in unexpected levels of inflammation or encapsulation.

Locations

Country	Name	City	State
United States	Ohio Pain Clinic	Dayton	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Neuronoff, Inc	Ohio Pain Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	28 days