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

November 14, 2025 updated by: DJO UK Ltd

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

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).

Study Overview

Status

Recruiting

Conditions

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 accordance with their approved intended use, to comply with Medical Device Regulation (EU) 2017/745 (MDR) Article 61 and Part B of Annex XI.

Study Type

Observational

Enrollment (Estimated)

144

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Serris, France
        • Completed
        • Attal Cabinet
  • Italy
      • Caserta, Italy, 81100
        • Recruiting
        • Casertafisio
        • Contact:
      • Roma, Italy, 00199
        • Recruiting
        • Rachis Center
        • Contact:
        • Principal Investigator:
          • Stamatios Liaskos
  • United Kingdom
      • Peebles, United Kingdom, EH45
        • Recruiting
        • Dr Chad Woods Physiotherapy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

Inclusion Criteria:

  1. 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.
  2. Patient male or female with age ≥18 years old.
  3. 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:

  1. Patients participating in another clinical study or who have completed a clinical study less than 30 days prior to enrollment.
  2. Patients who for any reason e.g. significant co-morbidities or other reasons, are considered by the Investigator unsuitable for study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from treatment start to treatment end (about 6 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from treatment start to treatment end (about 6 weeks)
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
from treatment start to treatment end (about 6 weeks)
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
end of study (about 12 weeks)
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
through study completion, an average of 15 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 15 weeks
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
through study completion, an average of 15 weeks
Misuse or off-label use identification
Time Frame: end of treatment (about 6 weeks)
Identify misuse or off-label use of the Intelect® devices
end of treatment (about 6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DJO UK Ltd

Collaborators

Donawa Lifescience Consulting SRL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

January 30, 2025

First Posted (Actual)

February 5, 2025

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENOVIS-S-INP-0004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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