Musculoskeletal DisordersINTELECTNCT06809283
Observational Prospective PMCF Study to Confirm Performance and Safety of Intelect® Devices in Real World
An observational study of Musculoskeletal Disorders and Skeletal Disorder, run by DJO UK Ltd at 4 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Disorders, Skeletal Disorder, Muscle Disorder
- How many people
- 144 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 10 Mar 2025to 31 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
About this study
Official 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
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).
Read the 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.
- Keywords
- TENS, NMES, Ultrasound, Pain, ROM
- Medical subject headings
- Musculoskeletal Diseases, Muscular Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from treatment start to treatment end (about 6 weeks)
Secondary outcomes (4)
Muscle reeducation
Improvement in muscle re-education demonstrated by score on a digital dynamometer at the end of treatment compared to baseline in the NMES group
Measured: from treatment start to treatment end (about 6 weeks)
Range of motion (ROM) improvement
Maintenance or increasing of the ROM demonstrated by a goniometer the end of treatment compared to baseline in the NMES group
Measured: from treatment start to treatment end (about 6 weeks)
Clinical status improvement
Improvement in patient clinical status using the Global Clinical Assessment of improvement questionnaire at the end of the treatment in the NMES group
Measured: end of study (about 12 weeks)
Safety - adverse event rate
Proportion of patient experiencing an adverse event associated with device use
Measured: through study completion, an average of 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start10 Mar 2025
- Primary completion26 Feb 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- DJO UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Donawa Lifescience Consulting S.r.l.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809283
- Sponsor's protocol ID
- ENOVIS-S-INP-0004
- Acronym
- INTELECT
- Status last verified
- Aug 2026
- First submitted
- 27 Jan 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06809283
- Acronym / sponsor ID
- INTELECT / ENOVIS-S-INP-0004
- Keywords
- TENS, NMES, Ultrasound, Pain, ROM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- DJO UK LtdIndustry (pharma, biotech, devices)
- Collaborators
- Donawa Lifescience Consulting S.r.l.
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Muscle reeducation
Time frame: 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)
Clinical status improvement
Time frame: end of study (about 12 weeks)
Safety - adverse event rate
Time frame: through study completion, an average of 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Disorders and Skeletal Disorder, run by DJO UK Ltd at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction (time frame: from treatment start to treatment end (about 6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.