Innovation in medical textiles: clinical trial approved with pre-marketing medical device (DZero)

Favorable opinion obtained from the Territorial Ethics Committee (CET) of the Ospedale Maggiore della Carità in Novara on the protocol for the clinical study focused on the potential beneficial effects of the new Class I Medical Device, DZero. 

On December 20th, 2024, Research Module 2 of the TINCARE flagship project achieved a significant milestone to move forward with research activities related to the new wearable device, DZero. This important step marks the beginning of an innovative project aimed at exploring the effectiveness of a smart fabric containing nanoceramic particles to improve the quality of life of patients suffering from musculoskeletal pain.  

The pre-post study design aims to evaluate the impact of the DZero T-shirt on patients' quality of life, focusing on musculoskeletal pain in the lumbar and cervical area before and after wearing DZero. Among the secondary objectives, the study will examine perceived well-being, comfort and pain reduction during normal daily activities. 

DZero represents a significant innovation in the field of medical devices. Utilizing FIR (Far Infrared Radiation) technology, this intelligent tissue uses nano-ceramic particles to improve microcirculation, reduce inflammation and promote muscle relaxation. It is a non-invasive solution that potentially offers an effective alternative for the management of musculoskeletal pain, assuming an improvement in patients' quality of life without the use of medication. 

The project will be carried out in a single-centre mode at the SS Antonio e Biagio e Cesare Arrigo University Hospital of Alessandria. data collection will take place in multiple phases, monitoring the effectiveness of the device over time.  

The DZero study offers new perspectives for the treatment of musculoskeletal pain, representing a step forward in the search for innovative and sustainable solutions for human well-being.