Observational Prospective Post Market Clinical Follow-up Study to Confirm Safety and Performance of Chattanooga Intelect4 Devices in Real World Use

What this Trial Is About

This research aims to confirm the safety and performance of several Chattanooga Intelect4 devices in real-world use for patients with musculoskeletal and skeletal muscle disorders. The study is a post-market, international, multi-center, prospective observational investigation designed to comply with European Medical Device Regulation requirements. It focuses on patients treated according to current clinical practice to ensure ongoing benefit-risk acceptability and to detect any misuse or off-label use of the devices. Participants will be treated with various Intelect4 devices, including those providing TENS, ultrasound (US), and neuromuscular electrical stimulation (NMES). Two groups are studied: one with acute or chronic musculoskeletal or post-operative pain treated with TENS alone, US alone, or both; and another with skeletal muscle deficits treated with NMES alone or combined with US. Treatments follow standard clinical practice at each site. The study observes treatment effects over about 6 weeks, with further follow-up to about 12 weeks. During the study, participants will undergo evaluations including pain reduction, muscle reeducation, range of motion improvement, and overall clinical status. Safety is monitored by recording adverse events throughout the average 15-week study period. Data collection relies on routine clinical assessments, and participants provide informed consent. The study helps characterize how these devices perform and are used in everyday clinical settings over time.

Observational Prospective PMCF Study to Confirm Performance and Safety of Intelect® Devices in Real World