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Basic Assessment of Safety and Minimally Invasive Stimulation Via Injectrode

NCT04672096 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-04-19

Study results available
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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

Interventions

DEVICE

Neuronoff BASMATI Injectrode

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

Sponsors & Collaborators

  • Ohio Pain Clinic

    collaborator OTHER

  • Neuronoff, Inc

    lead INDUSTRY

Principal Investigators

  • Amol Soin, MD · Ohio Pain Clinic

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-04
Primary Completion
2021-05-21
Completion
2021-05-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04672096 on ClinicalTrials.gov