NCT06809283 Observational Prospective PMCF Study to Confirm Performance and Safety of Intelect® Devices in Real World
| NCT ID | NCT06809283 |
| Status | Recruiting |
| Phase | — |
| Sponsor | DJO UK Ltd |
| Condition | Musculoskeletal Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 144 participants |
| Start Date | 2025-03-10 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 144 participants in total. It began in 2025-03-10 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06809283 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Musculoskeletal Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06809283 currently recruiting?
Yes, NCT06809283 is actively recruiting participants. Contact the research team at elena.arcangeli@enovis.com for enrollment information.
Where is the NCT06809283 trial being conducted?
This trial is being conducted at Serris, France, Caserta, Italy, Roma, Italy, Peebles, United Kingdom.
Who is sponsoring the NCT06809283 clinical trial?
NCT06809283 is sponsored by DJO UK Ltd. The trial plans to enroll 144 participants.