Health Trials

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

144 Participants
are grouped into 2 trial groups

Locations

4
France
Attal Cabinet Serris France
Italy
Casertafisio81100, Caserta Italy
Rachis Center00199, Roma Italy
United Kingdom
Dr Chad Woods PhysiotherapyEH45, Peebles United Kingdom

Sponsors and collaborators

DJO UK Ltd

Lead sponsor

Donawa Lifescience Consulting SRL

Collaborator

Source ClinicalTrials.gov