Status:
COMPLETED
Post-Market Clinical Follow-up HVS on Increased Circulation, RPW2 and Cefar TENS
Lead Sponsor:
DJO UK Ltd
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 l...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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)
Key Trial Info
Start Date :
September 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06590610
Start Date
September 5 2024
End Date
November 4 2024
Last Update
November 17 2025
Active Locations (1)
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1
The Whiteley Clinic
Guildford, United Kingdom, GU2 7RF