MedTrace Logo

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

NCT06590610 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-11-17

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • DJO UK Ltd

    lead INDUSTRY

Principal Investigators

  • Mark Whiteley, MD, Surgeon · The Whiteley Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-05
Primary Completion
2024-11-04
Completion
2024-11-04

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06590610 on ClinicalTrials.gov