Post-Market Clinical Follow-up HVS on Increased Circulation, RPW2 and Cefar TENS (NCT06590610) | Clinical Trial Compass
CompletedNot Applicable
Post-Market Clinical Follow-up HVS on Increased Circulation, RPW2 and Cefar TENS
United Kingdom20 participantsStarted 2024-09-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PV - Peak venous velocity (cm/s) will be assessed by Duplex Ultrasound (Philips EPIQ 7)
Timeframe: 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.
. 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