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

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Stratus Medical Initiates Enrolment of Participants in Nimbus RF Device Clinical Trial

Stratus Medical, a medical device company, has recently announced the initiation of enrolment for its new clinical trial of the Nimbus RF Device. The trial is designed to evaluate the safety and effectiveness of the device in treating patients with chronic pain.

The Nimbus RF Device is a minimally invasive, non-surgical treatment option for chronic pain. It uses radiofrequency energy to target and reduce pain-causing nerve fibers. The device is designed to be used in conjunction with physical therapy, lifestyle changes, and other treatments to help patients manage their chronic pain.

The clinical trial will involve a total of 60 participants who have been diagnosed with chronic pain. Participants will be randomly assigned to one of two groups: one group will receive the Nimbus RF Device treatment and the other group will receive a placebo treatment. The trial will last for 12 weeks and participants will be monitored throughout the duration of the study. The primary outcome measure of the trial will be a reduction in pain scores as measured by the Visual Analog Scale (VAS).

The results of the trial will be used to determine the safety and effectiveness of the Nimbus RF Device in treating chronic pain. If successful, the device could provide an alternative treatment option for those suffering from chronic pain. It could also provide an effective way to reduce the need for opioid medications, which can be addictive and have potentially dangerous side effects.

Stratus Medical is hopeful that the results of the trial will demonstrate the efficacy of the Nimbus RF Device in treating chronic pain. The company is committed to providing safe and effective treatments for those suffering from chronic pain and is excited to see what the results of this trial will bring.

Source: Plato Data Intelligence: PlatoAiStream

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