Actively Recruiting
Observational Prospective PMCF Study to Confirm Performance and Safety of Intelect® Devices in Real World
Led by DJO UK Ltd · Updated on 2025-11-17
144
Participants Needed
4
Research Sites
90 weeks
Total Duration
On this page
Sponsors
D
DJO UK Ltd
Lead Sponsor
D
Donawa Lifescience Consulting SRL
Collaborating Sponsor
AI-Summary
What this Trial Is 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).
CONDITIONS
Official Title
Observational Prospective PMCF Study to Confirm Performance and Safety of Intelect® Devices in Real World
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with musculoskeletal and skeletal muscle deficit disorders planned to be treated with any Intelect4 device as per clinical practice
- Male or female patients aged 18 years or older
- Able to provide written informed consent
- For patients in France: affiliated with or beneficiary of the social security system
You will not qualify if you...
- Participation in another clinical study currently or completed less than 30 days before enrollment
- Considered unsuitable for study participation by the investigator due to significant co-morbidities or other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Attal Cabinet
Serris, France
Completed
2
Casertafisio
Caserta, Italy, 81100
Actively Recruiting
3
Rachis Center
Roma, Italy, 00199
Actively Recruiting
4
Dr Chad Woods Physiotherapy
Peebles, United Kingdom, EH45
Actively Recruiting
Research Team
E
Elena Arcangeli
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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