Observational Prospective PMCF Study to Confirm Performance and Safety of Intelect® Devices in Real World
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDJO UK Ltd
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 groupsSponsors and collaborators
DJO UK Ltd
Lead sponsor
Donawa Lifescience Consulting SRL
Collaborator
Source ClinicalTrials.gov