N/A
N=22
REVITIVE for the Treatment of Patients With Venous Insufficiency
Venous Insufficiency · Oedema · Varicose Veins
Bottom Line
View on ClinicalTrials.gov: NCT02114307 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV — 102.4; -9.1 percentage change — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- REVITIVE IX (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV |
102.4; -9.1 | 0.001 sig |
| SECONDARY Changes in Limb Swelling, Volume |
5377; 5107; 5422; 5208; 5500; 5143 | 0.0023 sig |
| SECONDARY Clinical Symptoms |
-11.8; 6.4 | 0.127 |
Summary
To investigate the efficacy of an electrical stimulation (using the REVITIVE IX device) in treating patients with venous insufficiency.
Eligibility Criteria
Inclusion Criteria
- Ability to understand the study and provide meaningful written informed consent for the study.
- Willing, able, and committed to participate in the procedures for the full length of the study.
- All ethnic groups, male or female above the age of 18 years.
- Diagnosis of chronic venous insufficiency (C2-C5 CEAP classified)
- Be of non-childbearing potential; or using adequate contraception and have a negative urine pregnancy test result within 24 hours if appropriate before using the device.
- Blood pressure currently under moderate control (<160/100mmHg)
- No current foot ulceration.
Exclusion Criteria
- Has insufficient ability to understand the subject information sheet, consent form and verbal instruction.
- Has an unstable condition (eg psychiatric disorder, a recent history of substance abuse or otherwise thought to be unreliable or incapable of complying wight he requirements of the clinical investigational plan (CIP).
- Has any metal implants.
- Pregnant.
- Has a cardiac pacemaker, AICD or other implanted electrical device.
- Has an existing DVT.
- Has an acute medical condition other than chronic venous insufficiency.
- Has recent lower limb injury or lower back pain.
- Has current foot ulceration or other skin ulcers.
- Has cardiovascular disease.
- Has foot deformities.
- Has any disorder that, in the opinion of the investigator, might interfere with the conduct of the study.
- Has an ABPI < 0.8.
Data sourced from ClinicalTrials.gov (NCT02114307). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.