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

Last updated: March 18, 2025
Sponsor: DJO UK Ltd
Overall Status: Active - Recruiting

Phase

N/A

Condition

Musculoskeletal Diseases

Treatment

N/A

Clinical Study ID

NCT06809283
ENOVIS-S-INP-0004
  • Ages > 18
  • All Genders

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with musculoskeletal and skeletal muscle deficit disorders assigned to betreated with any of the Intelect® devices according to the current clinical practiceat 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 affiliatedto the social security system or to be beneficiary of such system

Exclusion

Exclusion Criteria:

  1. Patients participating in another clinical study or who have completed a clinicalstudy less than 30 days prior to enrollment.

  2. Patients who for any reason e.g. significant co-morbidities or other reasons, areconsidered by the Investigator unsuitable for study participation.

Study Design

Total Participants: 144
Study Start date:
March 10, 2025
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Attal Cabinet

    Serris,
    France

    Site Not Available

  • Casertafisio

    Caserta, 81100
    Italy

    Active - Recruiting

  • Dr Chad Woods Physiotherapy

    Peebles, EH45
    United Kingdom

    Active - Recruiting

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