Status:
RECRUITING
Observational Prospective PMCF Study to Confirm Performance and Safety of Intelect® Devices in Real World
Lead Sponsor:
DJO UK Ltd
Collaborating Sponsors:
Donawa Lifescience Consulting SRL
Conditions:
Musculoskeletal Disorders
Skeletal Disorder
Eligibility:
All Genders
18+ years
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 o...
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 a...
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.
Key Trial Info
Start Date :
March 10 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT06809283
Start Date
March 10 2025
End Date
December 1 2026
Last Update
November 17 2025
Active Locations (4)
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1
Attal Cabinet
Serris, France
2
Casertafisio
Caserta, Italy, 81100
3
Rachis Center
Roma, Italy, 00199
4
Dr Chad Woods Physiotherapy
Peebles, United Kingdom, EH45