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

NCT06809283 | Recruiting

• 1 other identifier: ENOVIS-S-INP-0004
• Study Type: observational
• Target: 144
• Locations: 3 countries
• Sites: 4

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 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

Keywords

TENS; NMES; Ultrasound; Pain; ROM

Outcome Measures

Primary Outcomes (1)

• Pain reduction

  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

  from treatment start to treatment end (about 6 weeks)

Secondary Outcomes (4)

• Muscle reeducation

  from treatment start to treatment end (about 6 weeks)

• Range of motion (ROM) improvement

  from treatment start to treatment end (about 6 weeks)

• Clinical status improvement

  end of study (about 12 weeks)

• Safety - adverse event rate

  through study completion, an average of 15 weeks

Other Outcomes (3)

• Waveforms assessment

  through study completion, an average of 15 weeks

• Electrodes assessment

  through study completion, an average of 15 weeks

• Misuse or off-label use identification

  end of treatment (about 6 weeks)

Study Arms (2)

TENS/US group

Patient affected by acute or chronic musculoskeletal pain or affected by post-operative pain that will be treated with TENS alone, US alone or TENS + US according to the current standard clinical practice at site. Data from patients in this group will be used to determine the primary study objective, some of the exploratory objectives and the safety objectives.

NMES group

Patients affected by skeletal muscle deficit disorders who benefit form muscle re-education and/or maintaining/increasing the range of motion will be treated with NMES alone or NMES + US according to the current standard clinical practice at site. Data from patients in this group will be used to determine the secondary study objective, some of the exploratory objectives and the safety objectives

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with musculoskeletal and skeletal muscle deficit disorders planned to be treated with any of the Intelect® devices who spontaneously went to any of the selected sites for receiving a treatment. For the purpose of determining the type of performance data to be collected, patients will be assigned to two groups: TENS/US group or NMES group based on the treatment they receive during their first session.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• DJO UK Ltd: lead
• Donawa Lifescience Consulting SRL: collaborator

Study Sites (4)

Attal Cabinet

Serris, France

COMPLETED

Casertafisio

Caserta, 81100, Italy

RECRUITING

Rachis Center

Roma, 00199, Italy

RECRUITING

Dr Chad Woods Physiotherapy

Peebles, EH45, United Kingdom

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases; Muscular Diseases; Pain

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Elena Arcangeli

CONTACT

3498772528; elena.arcangeli@enovis.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 5, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

FR (1); IT (2); GB (1)