Post-Market Clinical Follow-up HVS on Increased Circulation, RPW2 and Cefar TENS

NCT06590610 | Completed

• 1 other identifier: ENOVIS-S-INP-0007
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Healthy

Keywords

NMES; RPW2; CEFAR TENS; healthy volunteers; haemodynamic changes

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  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)

  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)

  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

Study Arms (1)

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.

Device: Radial pressure wave (RPW) - Intelect RPW2 Chattanooga

Interventions

Radial pressure wave (RPW) - Intelect RPW2 Chattanooga DEVICE

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

electrotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• DJO UK Ltd: lead

Study Sites (1)

The Whiteley Clinic

Guildford, GU2 7RF, United Kingdom

Location

Study Officials

• Mark Whiteley, MD, Surgeon

  The Whiteley Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 19, 2024
• Study Start: September 5, 2024
• Primary Completion: November 4, 2024
• Study Completion: November 4, 2024
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)