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

DJO UK Ltd

Status: Enrolling

Conditions: Musculoskeletal Disorders; Skeletal Disorder; Muscle Disorder

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06809283

ENOVIS-S-INP-0004

Details and patient eligibility

About

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).

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

144 participants in 2 patient groups

TENS/US group

Description:

Patient affected by acute or chronic musculoskeletal pain or affected by post-operative pain that will be treated with TENS alone, US alone or TENS + US according to the current standard clinical practice at site. Data from patients in this group will be used to determine the primary study objective, some of the exploratory objectives and the safety objectives.

NMES group

Description:

Patients affected by skeletal muscle deficit disorders who benefit form muscle re-education and/or maintaining/increasing the range of motion will be treated with NMES alone or NMES + US according to the current standard clinical practice at site. Data from patients in this group will be used to determine the secondary study objective, some of the exploratory objectives and the safety objectives