A Comprehensive Guide to Clinical Investigations: Content and Modifications in the EU – MDCG Guidance

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Stratus Medical Initiates Participant Recruitment for Nimbus RF Device Clinical Trial

Stratus Medical, a medical device company, recently announced the initiation of participant recruitment for the Nimbus RF Device clinical trial. The trial is designed to evaluate the safety and efficacy of the Nimbus RF Device in treating chronic pain.

The Nimbus RF Device is a non-invasive, radiofrequency (RF) device that is designed to provide relief from chronic pain. The device works by delivering a low-level RF energy to the affected area, which helps to reduce inflammation and pain. The device has been approved by the FDA for use in treating chronic pain and is now being evaluated in a clinical trial.

The clinical trial will involve a total of 40 participants who will be randomly assigned to either the treatment group or the control group. Participants in the treatment group will receive up to three treatments with the Nimbus RF Device, while participants in the control group will receive a placebo treatment. Participants will be monitored for up to 12 weeks after the initial treatment to assess the safety and efficacy of the device.

The primary outcome measure for the trial will be the change in pain intensity from baseline to 12 weeks after treatment. Secondary outcome measures include changes in quality of life, functional status, and patient satisfaction. The results of the trial will be used to determine whether the Nimbus RF Device is an effective treatment for chronic pain.

Stratus Medical is committed to providing safe and effective treatments for chronic pain. The company hopes that the results of this clinical trial will demonstrate that the Nimbus RF Device is an effective treatment option for those suffering from chronic pain. If successful, the device could provide relief to millions of people around the world who are living with chronic pain.

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