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

NCT06809283 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 144

Last updated 2025-11-17

No results posted yet for this study

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).

Conditions

  • Musculoskeletal Disorders
  • Skeletal Disorder
  • Muscle Disorder

Sponsors & Collaborators

  • Donawa Lifescience Consulting SRL

    collaborator UNKNOWN

  • DJO UK Ltd

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2026-08-31
Completion
2026-12-31

Countries

  • France
  • Italy
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06809283 on ClinicalTrials.gov