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Lumbar Injectrode Feasibility Evaluation

Recruiting
21 years and older
Both
Phase 1

The study is testing a new device, called the PNS Injectrode F1, to see if it can safely help muscles near the spine move when stimulated. This study will last for less than 28 days and involves putting a small device near a back nerve. It aims to check if the device can make these muscles work by using gentle electric signals from outside the body. Participants will need to visit the clinic on specified days for check-ups and follow-ups. The main tests involve getting a tiny device inserted, checking its effects, and then removing it.

  • **Study Duration**: Up to 28 days.
  • **Visits Needed**: At least 5 visits, including check-ins by email.
  • **Eligibility**: Must be over 21, healthy, and able to follow instructions.

This study is for people who are healthy, can tolerate minor electrical stimulation, and can follow the study's requirements. If you have certain medical conditions or use specific medical devices, you may not be eligible. The study will help learn more about using this device safely, but participation is voluntary and should be considered carefully. 😊

Study details
    Chronic Pain
    Lower Back Pain Chronic

NCT06206356

Neuronoff, Inc

24 January 2024

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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