Basic Assessment of Safety and Minimally Invasive Stimulation Via Injectrode

NCT04672096 | Completed Results DMC FDA Device

• 1 other identifier: NCP-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Lower Limb Pain

Keywords

Electrode; Injectable Electrode; Injectrode; Medical Device Safety

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Neuronoff BASMATI Injectrode

EXPERIMENTAL

Subjects will be provided with the placement of an Injectrode insert. The maximal placement duration will be 28 days.

Device: Neuronoff BASMATI Injectrode

Interventions

Neuronoff BASMATI Injectrode DEVICE

The 28 day temporary placement of a Basmati Injectrode does not result in unexpected levels of inflammation or encapsulation.

Also known as: Injectrode, BASMATI Injectrode

Neuronoff BASMATI Injectrode

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)).

Sponsors & Collaborators

• Neuronoff, Inc: lead
• Ohio Pain Clinic: collaborator

Study Sites (1)

Ohio Pain Clinic

Dayton, Ohio, 45458, United States

Location

Results Point of Contact

• Title: Jasmine Wilson
• Organization: Neuronoff, Inc.

jasmine@neuronoff.com

408-858-2612

Study Officials

• Amol Soin, MD

  Ohio Pain Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 17, 2020
• Study Start: December 4, 2020
• Primary Completion: May 21, 2021
• Study Completion: May 21, 2021
• Last Updated: April 19, 2024
• Results First Posted: April 19, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)