NCT06809283

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

Observational Prospective Post Market Clinical Follow-up (PMCF) Study to Confirm the Performance and Safety of the Chattanooga Intelect® Devices in Real World Use

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 144 (estimated)
• Sponsor: DJO UK Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

DJO UK Ltd (ENOVIS) is conducting this study to confirm the performance and safety of the Chattanooga Intelect® devices in real world use. This study will record post market clinical data on the use of a number of MDR-CE marked devices that are part of the Chattanooga Intelect® device family to ensure the continued acceptability of the benefit-risk ratio, and to identify possible systematic misuse or off-label use of the devices (Intelect® Mobile 2 Combo, Intelect® Mobile 2 Ultrasound, Intelect® Mobile 2 Electrotherapy (Stim), Intelect® Transport 2 Combo and Intelect® Transport 2 Ultrasound).

Detailed description

This clinical investigation is a post-market, real word, international, multi center, prospective, observational study to confirm the safety and performance of the Chattanooga Intelect® when used in accordance with their approved intended use, to comply with Medical Device Regulation (EU) 2017/745 (MDR) Article 61 and Part B of Annex XI.

Conditions

• Musculoskeletal Disorders
• Skeletal Disorder
• Muscle Disorder

Timeline

• Start date: 2025-03-10
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2025-02-05
• Last updated: 2025-11-17

Locations

4 sites across 3 countries: France, Italy, United Kingdom