NCT04672096

Basic Assessment of Safety and Minimally Invasive Stimulation Via Injectrode

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Neuronoff, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Chronic Lower Limb Pain

Interventions

Type	Name	Description
DEVICE	Neuronoff BASMATI Injectrode	The 28 day temporary placement of a Basmati Injectrode does not result in unexpected levels of inflammation or encapsulation.

Timeline

• Start date: 2020-12-04
• Primary completion: 2021-05-21
• Completion: 2021-05-21
• First posted: 2020-12-17
• Last updated: 2024-04-19
• Results posted: 2024-04-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study