Serris

Researchers are conducting an international, multi-center, post-market observational study to confirm the safety and performance of the Chattanooga Intelect4 devices when used as intended in real-world clinical practice. The study focuses on patients with musculoskeletal and skeletal muscle disorders and aims to ensure that the benefit-risk balance of these devices remains acceptable under Medical Device Regulation (EU) 2017/745 standards. This research also seeks to identify any patterns of misuse or off-label use of several Intelect4 devices including Mobile 2 Combo, Mobile 2 Ultrasound, Mobile 2 Electrotherapy (Stim), Transport 2 Combo, and Transport 2 Ultrasound models. Participants receive treatment according to current clinical practice using one or more of the approved Intelect4 devices as determined by their healthcare providers. The study does not intervene with treatment but observes the real-world use of these devices. It collects data over a period of approximately six weeks, focusing on how the devices perform and their safety during typical patient care. During the study, participants will be monitored for pain reduction from the start to the end of treatment. Clinical data will be gathered through routine assessments aligned with standard care at each site. Safety and performance data will be recorded to help ensure ongoing device acceptability and to detect any potential issues related to device use. Participants are involved for the duration of their treatment, with no additional interventions beyond usual care.

Researchers are evaluating the effectiveness of LightForce Therapy Lasers combined with standard physiotherapy and exercise programs for reducing pain in people with shoulder soft tissue inflammation caused by Subacromial Impingement Syndrome (SAIS) or Rotator Cuff Tendinopathy (RCT). This is a post-market, international, multi-center, randomized, sham-controlled, single-blind study designed to assess both the performance and safety of LightForce Therapy Lasers as used in normal clinical practice, in compliance with medical device regulations. The goal is to compare the laser therapy plus standard care against a sham laser plus standard care in reducing shoulder pain.