Actualités RCTS - Facultatif
The RegenLife study illustrates RCTs’ expertise in conducting complex pre-CE marking clinical investigations for innovative medical devices. This pilot trial evaluated the safety and performance of a photobiomodulation device designed to treat sportspeople suffering from acute concussion syndrome.
RegenLife is a randomized, controlled, open-label, pilot clinical investigation conducted across 10 countries, involving 128 sites and 3,604 patients. The primary objective was to assess the safety and performance of photobiomodulation therapy in real-world conditions before CE marking approval.
Acute concussion syndrome is a growing concern among athletes. Photobiomodulation therapy offers a non-invasive solution to accelerate recovery and improve patient outcomes. This study provided critical evidence to support regulatory submissions and CE marking.
RCTs managed every aspect of the investigation, including medical writing, project management, regulatory submissions, data management, site management, and statistical analysis. Our team ensured compliance with international standards and delivered robust data for regulatory approval.
The study confirmed the safety and performance of the device, paving the way for CE marking and future applications in neurological disorders such as Alzheimer’s disease. This success demonstrates RCTs’ leadership in medical device clinical investigations.
Discover how RCTs can support your medical device development with expertise in pre-CE marking clinical investigations and regulatory strategy.
To learn more about the RegenLife device and its innovative photobiomodulation technology, visit RegenLife official website.
