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

Recruiting

• Conditions: Musculoskeletal Disorders; Skeletal Disorder; Muscle Disorder

• Registration Number: NCT06809283
• Lead Sponsor: DJO UK Ltd

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.

Study Timeline

• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-01-30
• Study First Posted: 2025-02-05
• Status Verified: 2025-03
• Study Start: 2025-03-10
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21
• Primary Completion: 2026-08
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 144

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain reduction	from treatment start to treatment end (about 6 weeks)	Pain reduction measured with Visual Analog Scale (VAS) (in a scale 0-100 mm, where 0 is no pain and 100 is the worst possible pain) at end of treatment compared to pre-treatment (baseline) VAS in the TENS/US group

Secondary Outcome Measures

Name	Time	Method
Muscle reeducation	from treatment start to treatment end (about 6 weeks)	Improvement in muscle re-education demonstrated by score on a digital dynamometer at the end of treatment compared to baseline in the NMES group
Range of motion (ROM) improvement	from treatment start to treatment end (about 6 weeks)	Maintenance or increasing of the ROM demonstrated by a goniometer the end of treatment compared to baseline in the NMES group
Clinical status improvement	end of study (about 12 weeks)	Improvement in patient clinical status using the Global Clinical Assessment of improvement questionnaire at the end of the treatment in the NMES group
Safety - adverse event rate	through study completion, an average of 15 weeks	Proportion of patient experiencing an adverse event associated with device use

Trial Locations

Locations (3)

Attal Cabinet; 🇫🇷 Serris, France

Casertafisio; 🇮🇹 Caserta, Italy

Dr Chad Woods Physiotherapy; 🇬🇧 Peebles, United Kingdom