Observational Prospective PMCF Study to Confirm Performance and Safety of Intelect® Devices in Real World
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDJO UK Ltd
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
144 Participants
are grouped into 2 trial groupsGroup A: TENS/US group
Group B: NMES group
Trial outcomes
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
Time frame
from treatment start to treatment end (about 6 weeks)Secondary outcomes
1
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
Time frame
from treatment start to treatment end (about 6 weeks)2
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
Time frame
from treatment start to treatment end (about 6 weeks)3
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
Time frame
end of study (about 12 weeks)4
Safety - adverse event rate
Proportion of patient experiencing an adverse event associated with device use
Time frame
through study completion, an average of 15 weeksOther outcomes
1
Waveforms assessment
Assess the performance and safety of the different waveforms used in the TENS and NMES modalities
Time frame
through study completion, an average of 15 weeks2
Electrodes assessment
Assess the performance and safety of various types of electrodes used with the Intelect® devices for TENS or NEMS modalities
Time frame
through study completion, an average of 15 weeks3
Misuse or off-label use identification
Identify misuse or off-label use of the Intelect® devices
Time frame
end of treatment (about 6 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
DJO UK Ltd
Lead sponsor
Donawa Lifescience Consulting SRL
Collaborator
Source ClinicalTrials.gov