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

Launched by DJO UK LTD · Jan 30, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how well and safely certain Intelect® devices work when used by patients in real-life situations. These devices are designed to help treat various muscle and skeletal disorders. The study will collect data from patients using these devices to make sure they continue to provide benefits and to check for any misuse or incorrect use. The devices being studied include the Intelect® Mobile 2 Combo, Intelect® Mobile 2 Ultrasound, Intelect® Mobile 2 Electrotherapy, Intelect® Transport 2 Combo, and Intelect® Transport 2 Ultrasound.

To participate in this study, you need to be at least 18 years old and have a musculoskeletal or muscle disorder that requires treatment with one of the Intelect® devices. It's important that you can provide written consent to participate. However, if you're involved in another clinical trial or have health issues that make you unsuitable for this study, you won't be eligible. If you join the study, you can expect to use one of the Intelect® devices as part of your treatment, and your experience will help researchers ensure these devices are effective and safe for everyone.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. Patient male or female with age ≥18 years old.
• • 3. 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 Criteria:
• • 1. Patients participating in another clinical study or who have completed a clinical study less than 30 days prior to enrollment.
• • 2. Patients who for any reason e.g. significant co-morbidities or other reasons, are considered by the Investigator unsuitable for study participation.