Basic Assessment of Safety and Minimally Invasive Stimulation Via Injectrode
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Safety Issues
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Device Feasibility
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The proposed study is a prospective, single-center, single-arm, non-randomized design. Up to 10 study subjects will be provided with the placement of an Injectrode insert. The maximal placement duration will be 28 days. Subjects selected to participate in the trial are healthy without any preexistin...
The proposed study is a prospective, single-center, single-arm, non-randomized design. Up to 10 study subjects will be provided with the placement of an Injectrode insert. The maximal placement duration will be 28 days. Subjects selected to participate in the trial are healthy without any preexisting condition indicated to be treated. Each subject will be followed during the trial period of approximately 50 days, including the time for screening and post-explant follow-up. The study will end when the last subject has completed the trial period and exited. After exit from the clinical study, subjects will continue to be followed by their physician per standard of care. All device and procedure-related adverse events (AEs) and unanticipated problems (UPs) will be collected and reported per the study protocol.
Tracking Information
- NCT #
- NCT04672096
- Collaborators
- Ohio Pain Clinic
- Investigators
- Principal Investigator: Amol Soin, MD Ohio Pain Clinic
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