Clinical trial NCT06809283: Observational Prospective PMCF Study to Confirm Performance and Safety of Intelect® Devices in Real World
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Musculoskeletal Disorders
Skeletal Disorder
Muscle Disorder
Keywords: TENS
NMES
Ultrasound
Pain
ROM
Lead sponsor: DJO UK Ltd
Sponsor class: INDUSTRY
First posted: 2025-02-05
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with musculoskeletal and skeletal muscle deficit disorders planned to be treated with any of the Intelect® devices who spontaneously went to any of the selected sites for receiving a treatment. For the purpose of determining the type of performance data to be collected, patients will be assigned to two groups: TENS/US group or NMES group based on the treatment they receive during their first session.

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).

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.

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.

Primary outcomes:
measure: Pain reduction
timeFrame: from treatment start to treatment end (about 6 weeks)
Secondary outcomes:
measure: Muscle reeducation
timeFrame: from treatment start to treatment end (about 6 weeks)
measure: Range of motion (ROM) improvement
timeFrame: from treatment start to treatment end (about 6 weeks)
measure: Clinical status improvement
timeFrame: end of study (about 12 weeks)
measure: Safety - adverse event rate
timeFrame: through study completion, an average of 15 weeks
Other outcomes:
measure: Waveforms assessment
timeFrame: through study completion, an average of 15 weeks
measure: Electrodes assessment
timeFrame: through study completion, an average of 15 weeks
measure: Misuse or off-label use identification
timeFrame: end of treatment (about 6 weeks)
Locations:
city: Serris
country: France
facility: Attal Cabinet
city: Caserta
country: Italy
facility: Casertafisio
city: Peebles
country: United Kingdom
facility: Dr Chad Woods Physiotherapy
Study officials:
References: