RecruitingNCT06809283

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

Sponsor

DJO UK Ltd

Enrollment

144 participants

Start Date

Mar 10, 2025

Study Type

OBSERVATIONAL

Conditions

Musculoskeletal Disorders Muscle Disorder Skeletal Disorder

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria2

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.

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