Confirming the safety and performance of Intelect® devices for musculoskeletal disorders

Observational Prospective Post Market Clinical Follow-up (PMCF) Study to Confirm the Performance and Safety of the Chattanooga Intelect® Devices in Real World Use

This study is testing how safe and effective Chattanooga Intelect® devices are for treating muscle and joint problems in real-world settings.

Quick facts

• Study type: Observational
• Enrollment: 144 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: DJO UK Ltd (industry)
• Locations: 4 sites (Serris and 3 other locations)
• Trial ID: NCT06809283 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather real-world clinical data on the performance and safety of various Chattanooga Intelect® devices used for treating musculoskeletal disorders. It will involve multiple centers and will assess the devices' compliance with their intended use as per medical regulations. The study will also monitor for any potential misuse or off-label use of these devices to ensure patient safety and efficacy.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with musculoskeletal or skeletal muscle deficit disorders who are prescribed treatment with Intelect® devices.

Not a fit: Patients with significant co-morbidities or those currently participating in another clinical study may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of the effectiveness and safety of Intelect® devices, leading to improved treatment options for patients with musculoskeletal disorders.

How similar studies have performed: Other studies have shown success in confirming the safety and efficacy of medical devices in real-world settings, making this approach both relevant and potentially beneficial.

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.

Where this trial is running

Serris and 3 other locations

• Attal Cabinet — Serris, France (COMPLETED)
• Casertafisio — Caserta, Italy (RECRUITING)
• Rachis Center — Roma, Italy (RECRUITING)
• Dr Chad Woods Physiotherapy — Peebles, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Elena Arcangeli

Conditions: Musculoskeletal Disorders, Skeletal Disorder, Muscle Disorder, TENS, NMES, Ultrasound, Pain, ROM