An interventional study of Radial pressure wave (RPW) - Intelect RPW2 Chattanooga in Healthy, sponsored by DJO UK Ltd. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-17.
Sponsored by DJO UK Ltd · Not applicable, Interventional, and Treatment
The study is a prospective, single-center, open-label, post-market investigational study on healthy volunteers conducted in the United Kingdom.
Sponsor is conducting this prospective study to collect PMCF data on the safety and performance of Intelect RPW2 and CEFAR TENS devices in accordance with Medical Device Regulation (EU) 2017/745 (MDR) Article 61 and Part B of Annex XIV.
The aim of this study is to measure the hemodynamic changes in the lower limb consequent to the use of CEFAR TENS via neuromuscular electrical stimulation (NMES) and to the use of Intelect® RPW2 via radial pressure waves (RPW).
The hypothesis of this study is that the application of both medical devices, CEFAR TENS or Intelect® RPW2 to the calf muscles will increase venous return, as a local and temporary effect of the treatment.
The hemodynamic measurements will be recorded with a Duplex ultrasound at baseline before the treatment as steady state condition, during the treatment session at several timepoints and after each treatment's end.
The selected 20 healthy subjects will undergo one treatment per device for both electrostimulation and radial pressure wave therapy on both the right and left Gastrocnemius, device placement on each leg will be randomized prior to application with each device having an equal chance of being placed on the either leg (dominant and non-dominant). Each subject will receive treatment via the Intelect® RPW2 device to either the right or left leg and afterwards the subject will receive treatment via the CEFAR TENS device to the opposite leg as per the randomization table.
The capability of the radial pressure waves therapy (Intelect® RPW2) and NMES (CEFAR TENS) to improve local and temporarily hemodynamics on the treated limb will be investigated.
The subject will firstly receive RPW treatment and secondly receive NMES treatment this will be consistent for all subjects, as an arbitrary decision to be consistent throughout the whole study with the treatment's application.
Subjects will be positioned in the prone decubitus position for a minimum of 3 minutes or until the steady state condition is reached; automated blood pressure cuff will be used to record blood pressure and pulse from upper arm. Following the rest period the measurement by means of a Duplex Ultrasound will be performed: Peak venous velocity, Ejected volume, Time averaged Mean venous velocity, and Volume flow will be recorded in the leg to be treated with RPW. Subjects will remain in this position for the duration of the treatment (corresponding to 2 minutes and 30 seconds by RPW and 10 minutes for NMES), the study staff will apply the Intelect® RPW2 device to either the right or left leg according to the randomization plan. During the RPW treatment the hemodynamic parameters in the subject leg will be measured at 30 seconds, 1 minute, 1 minute and 30 seconds, 2 minutes and 2 minutes and 30 seconds after RPW treatment is started and at 1, 2, 5 and 10 minutes after RPW treatment end. Arterial blood pressure and heart rate measurement will be recorded after RPW treatment end from upper arm.
Then the study staff will apply the CEFAR TENS device to the opposite leg. During the NMES treatment the hemodynamic parameters in the subject leg will be measured at 30 seconds, 1, 2 ,5, 8 and 10 minutes after NMES treatment is started and at 1, 2, 5 and 10 minutes after treatments end. Blood pressure and pulse will be recorded after NMES treatment end from upper arm.
The treatment with Intelect® RPW2 and CEFAR TENS devices will be performed by the study staff after training on the devices use.
A Vascular Technologist will perform the hemodynamic measurements by Duplex Ultrasound device.
A virtual follow up visit will be scheduled one week following treatment.
DJO UK Ltd is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
All the selected 20 healthy subjects will undergo the radial pressure waves treatment on one leg at the Gastrocnemius, left or right leg as per randomization. Afterwards each patient will undergo NMES electrostimulation treatment on the opposite leg at the Gastrocnemius.
Device: Radial pressure wave (RPW) - Intelect RPW2 Chattanooga
RPW treatment on one leg at the Gastrocnemius and NMES electrostimulation on the opposite leg. RPW or NMES treatment on each leg will be randomized prior to application with each device having an equal chance of being placed on the either leg (dominant and non-dominant).
Also known as: NMES electrostimulation - CEFAR TENS Chattanooga
PV - Peak venous velocity (cm/s) will be assessed by Duplex Ultrasound (Philips EPIQ 7)
PV is here defined as primary endpoint to verify the hypothesis of hemodynamic changes and blood flow improvements due to the applied treatments with the devices under investigation within this study. The effects of the application of CEFAR TENS and Intelect® RPW2 on the calf muscles on local peak venous velocity will be compared to steady state values. The comparison between the hemodynamic measurements collected during and following each treatment has been performed and the pre-treatment steady state values will provide evidence of the hemodynamic changes hypothesized
Time frame: PV assessment will be on the same day of the RPW treatment: before, during, and at treatment's end on one leg. PV assessment will be on the same day of the NMES treatment: before, during, and at treatment's end on the opposite leg.
EV - Ejected volume (ml) will be assessed by Duplex Ultrasound (Philips EPIQ 7)
This secondary endpoint has been identified as parameter commonly evaluated in the scientific literature on similar studies to evaluate the beneficial effect of NMES treatment on blood circulation.
Time frame: EV assessment will be on the same day of the RPW treatment: before, during, and at treatment's end on one leg. EV assessment will be on the same day of the NMES treatment: before, during, and at treatment's end on the opposite leg
Time averaged Mean venous velocity (cm/s) will be assessed by Duplex Ultrasound (Philips EPIQ 7)
This secondary endpoint has been identified as parameter commonly evaluated in the scientific literature on similar studies to evaluate the beneficial effect of NMES treatment on blood circulation.
Time frame: Velocity assessment will be on the same day of the RPW treatment: before, during, and at treatment's end on one leg.Velocity assessment will be on the same day of the NMES treatment: before, during, and at treatment's end on the opposite leg
Volume flow (VF) in mL/min will be assessed by Duplex Ultrasound (Philips EPIQ 7)
This secondary endpoint has been identified as parameter commonly evaluated in the scientific literature on similar studies to evaluate the beneficial effect of NMES treatment on blood circulation.
Time frame: Volume flow assessment will be on the same day of the RPW treatment: before, during, and at treatment's end on one leg.Volume flow assessment will be on the same day of the NMES treatment: before, during, and at treatment's end on the opposite leg
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