Observational Prospective PMCF Study to Confirm Performance and Safety of Intelect® Devices in Real World
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Musculoskeletal Disorders, Skeletal Disorder, Muscle Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Italy, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Observational Prospective Post Market Clinical Follow-up (PMCF) Study to Confirm the Performance and Safety of the Chattanooga Intelect® Devices in Real World Use
Overview
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).
Detailed description
This clinical investigation is a post-market, real word, international, multi center, prospective, observational study to confirm the safety and performance of the Chattanooga Intelect® when used in accordance with their approved intended use, to comply with Medical Device Regulation (EU) 2017/745 (MDR) Article 61 and Part B of Annex XI.
Primary outcome measures
- Pain reduction [Time frame: from treatment start to treatment end (about 6 weeks)]
Secondary outcome measures (4)
- Muscle reeducation [Time frame: from treatment start to treatment end (about 6 weeks)]
- Range of motion (ROM) improvement [Time frame: from treatment start to treatment end (about 6 weeks)]
- Clinical status improvement [Time frame: end of study (about 12 weeks)]
- Safety - adverse event rate [Time frame: through study completion, an average of 15 weeks]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Italy · 2 centers
- Casertafisio — Caserta
- Rachis Center — Roma
France · 1 center
- Attal Cabinet — Serris
United Kingdom · 1 center
- Dr Chad Woods Physiotherapy — Peebles
Identifiers
NCT: NCT06809283 · ENOVIS-S-INP-0004