Observational Prospective PMCF Study to Confirm Performance and Safety of Intelect® Devices in Real World
Recruiting now
Conditions studied: Musculoskeletal Disorders, Skeletal Disorder, Muscle Disorder
In brief
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).
Key facts
- Study ID
- NCT06809283
- Run by
- DJO UK Ltd
- People needed
- 144
- Starts
- 2025-03-10
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-11-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with musculoskeletal and skeletal muscle deficit disorders assigned to be treated with any of the Intelect® devices according to the current clinical practice at the selected sites and based on the opinion of the Investigator.
- Patient male or female with age ≥18 years old.
- Patient able to provide written informed consent. For France only: To be affiliated to the social security system or to be beneficiary of such system
You may not qualify if…
- Patients participating in another clinical study or who have completed a clinical study less than 30 days prior to enrollment.
- Patients who for any reason e.g. significant co-morbidities or other reasons, are considered by the Investigator unsuitable for study participation.
Where it is running
- Casertafisio — Caserta, Italy (enrolling)
- Rachis Center — Roma, Italy (enrolling)
- Dr Chad Woods Physiotherapy — Peebles, United Kingdom (enrolling)
- Attal Cabinet — Serris, France
Full record on ClinicalTrials.gov
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