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NCT Number: NCT06809283

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

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).

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Key information

Conditions

Musculoskeletal Disorders Muscle Disorder Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skeletal Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Attal Cabinet, Serris, France

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Pain reduction

    Time frame: 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 outcomes

  1. Muscle reeducation

    Time frame: 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

  2. Range of motion (ROM) improvement

    Time frame: 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

  3. Clinical status improvement

    Time frame: 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

  4. Safety - adverse event rate

    Time frame: through study completion, an average of 15 weeks

    Proportion of patient experiencing an adverse event associated with device use

Other outcomes

  1. Waveforms assessment

    Time frame: through study completion, an average of 15 weeks

    Assess the performance and safety of the different waveforms used in the TENS and NMES modalities

  2. Electrodes assessment

    Time frame: through study completion, an average of 15 weeks

    Assess the performance and safety of various types of electrodes used with the Intelect® devices for TENS or NEMS modalities

  3. Misuse or off-label use identification

    Time frame: end of treatment (about 6 weeks)

    Identify misuse or off-label use of the Intelect® devices

Study contacts

Contact information is provided by the study sponsor or research team.

Elena Arcangeli

CONTACT

[email protected]

3498772528 ext. 0039

Sponsors and collaborators

Lead sponsor

DJO UK Ltd

Industry

Collaborators

  • Donawa Lifescience Consulting S.r.l.

Registry information

Official study title

Observational Prospective Post Market Clinical Follow-up (PMCF) Study to Confirm the Performance and Safety of the Chattanooga Intelect® Devices in Real World Use

Acronym: INTELECT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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