HealthyNCT06590610
Post-Market Clinical Follow-up HVS on Increased Circulation, RPW2 and Cefar TENS
A study testing Radial pressure wave (RPW) - Intelect RPW2 Chattanooga in people with Healthy, run by DJO UK Ltd at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Radial pressure wave (RPW) - Intelect RPW2 Chattanooga
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Sep 2024to 4 Nov 2024
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects, both male and female, ≥ 18 years of age at the time of consent.
- Subject is available to attend all study appointments for the study duration
- Any Subject who has reviewed the IEC-approved consent form, has been properly consented per the protocol and has documented their consent to participate in the study by signing the Ethics-approved consent form.
Who cannot join
- Subjects with any cognitive impairment who prevent to understand the information provided and freely and autonomously provide and sign informed consent to participate in the study.
- Subject is pregnant or has plans of becoming pregnant for the duration of the study.
- Presence of cancerous tumours/Neoplastic tissue/lesions in treatment area (back lower limb of both legs)
- Subject possesses a prosthetic lower limb
- Diagnosed with diabetes
- Cortisone therapy ongoing or within the last 6 months before treatment
Show all 19Show fewer
- Diagnosed Haemophilia, Thrombosis, Deep vein thrombosis, phlebitis, varices, risk of haemorrhage, occlusive vascular disease or other coagulation disorders
- Treatment with anticoagulant pharmaceuticals
- Reduced sensitivity over the proposed area of treatment (back lower limb of both legs)
- Suspected or diagnosed cardiopathy
- Any history of cardiovascular disease e.g., cardiac arrhythmia and angina pectoris, arterial disease, circulatory insufficiency.
- Implanted electronic devices e.g., cardiac stimulator, implanted defibrillator or other implanted electronic/electrical device
- Hypertension (\> stage 2), ischemic heart disease and cerebrovascular diseases
- Peripheral vascular disease or serious arterial or venous circulation problems in any of the lower limbs.
- Systemic or local infection.
- Open wounds, rashes, swollen, red, infected, inflamed areas or skin eruptions at the site of treatment (back lower limb of both legs).
- Diagnosis of Epilepsy or has had any previous Epileptic episodes.
- Proven allergy to the study devices materials or electrodes.
- Recent surgery or metal implant present at the site of treatment (back lower limb of both legs)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Independent Temporary Effects of Intelect® RPW2 (Radial Pressure Wave) and Cefar TENS (NMES) Treatments on the Local Circuclation of Healthy Volunteers
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- Radial pressure wave (RPW) - Intelect RPW2 Chattanooga
- Keywords
- NMES, RPW2, CEFAR TENS, healthy volunteers, haemodynamic changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial pressure wave (RPW) - Intelect RPW2 ChattanoogaDevice
Also called NMES electrostimulation - CEFAR TENS 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).
| Study group | Role | What they receive |
|---|---|---|
| electrotherapy | Experimental | 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. Receives: Device: Radial pressure wave (RPW) - Intelect RPW2 Chattanooga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start5 Sep 2024
- Primary completion4 Nov 2024
- Study completion4 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- DJO UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Whiteley, MD, Surgeon, Principal investigator, The Whiteley Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590610
- Sponsor's protocol ID
- ENOVIS-S-INP-0007
- Status last verified
- Nov 2025
- First submitted
- 2 Sep 2024
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Independent Temporary Effects of Intelect® RPW2 (Radial Pressure Wave) and Cefar TENS (NMES) Treatments on the Local Circuclation of Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06590610
- Acronym / sponsor ID
- ENOVIS-S-INP-0007
- Conditions
- Healthy
- Keywords
- NMES, RPW2, CEFAR TENS, healthy volunteers, haemodynamic changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- DJO UK LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 4 Nov 2024 (actual)
- First posted
- 19 Sep 2024 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| electrotherapy | Experimental | Device: Radial pressure wave (RPW) - Intelect RPW2 ChattanoogaAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects, both male and female, ≥ 18 years of age at the time of consent.
- Subject is available to attend all study appointments for the study duration
- Any Subject who has reviewed the IEC-approved consent form, has been properly consented per the protocol and has documented their consent to participate in the study by signing the Ethics-approved consent form.
Key exclusion criteria (19 listed)
- Subjects with any cognitive impairment who prevent to understand the information provided and freely and autonomously provide and sign informed consent to participate in the study.
- Subject is pregnant or has plans of becoming pregnant for the duration of the study.
- Presence of cancerous tumours/Neoplastic tissue/lesions in treatment area (back lower limb of both legs)
- Subject possesses a prosthetic lower limb
- Diagnosed with diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radial pressure wave (RPW) - Intelect RPW2 ChattanoogaAlso: NMES electrostimulation - CEFAR TENS ChattanoogaRPW 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). | Device | electrotherapy |
Primary outcome
PV - Peak venous velocity (cm/s) will be assessed by Duplex Ultrasound (Philips EPIQ 7)
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.
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
3 secondary outcomes
EV - Ejected volume (ml) will be assessed by Duplex Ultrasound (Philips EPIQ 7)
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)
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)
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
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 17 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Mark Whiteley, MD, Surgeon principal investigator
The Whiteley Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial pressure wave (RPW) - Intelect RPW2 Chattanooga in people with Healthy, run by DJO UK Ltd at 1 site in United Kingdom.
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 19 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 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
PV - Peak venous velocity (cm/s) will be assessed by Duplex Ultrasound (Philips EPIQ 7) (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.). 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 17 Nov 2025.