Living with a swollen and painful leg?
If the pain, swelling, and sores from your leg make it difficult to stand, walk, and complete daily activities, you may be suffering from a condition called chronic venous insufficiency (CVI). CVI negatively impacts the quality of the lives of more than 2.5 million people in the U.S., so you are not alone. Researchers are currently enrolling participants in a new, clinical study for an FDA-designated breakthrough device for the treatment of CVI called the VenoValve.
Fill out the form below for more information
Thank you for your interest in being considered for the VenoValve clinical trial.* The following questions are for pre-screening purposes only and are not being used to diagnose any disease or to render medical advice or medical care.
By submitting the above information, you consent to being contacted by a study representative and to receiving clinical updates. You also agree that the information and accompanying photos may be used for pre-screening purposes for the clinical trial and in connection with the development of VenoValve.
To learn more about VenoValve and it’s previous trials go to: venovalve.com
Why participate in this study?
EnVVeno Medical Corporation is focused on setting new standards of care for the treatment of venous disease.
Getting to the source
When it comes to chronic venous insufficiency (CVI) in the deep veins of the leg, current treatment options only attempt to address the symptoms of the disease, and not the underlying cause. Deep venous CVI occurs when the valves inside the deep veins of the leg aren’t working as they should. Blood flows in the wrong direction, and pools in the lower leg, causing pain, itchiness, skin discoloration, and swelling. In severe cases, skin in the ankle area breaks down resulting in open sores that are difficult to treat.
The VenoValve is a replacement valve that is implanted into the deep veins of the leg to restore proper blood flow and reduce the pain, swelling, and other negative impacts of CVI.
A chance to help others like yourself
Having a painful and swollen leg from chronic venous insufficiency has a significant negative impact on the quality of your life and the lives of the other approximately 2.5 million CVI sufferers in the U.S. By participating in the VenoValve clinical trial, not only would you give yourself the opportunity to try the newest, FDA-designated breakthrough investigational treatment for CVI, but your participation may help other CVI sufferers have access to the VenoValve if upon completion of the clinical trial, the VenoValve qualifies for FDA approval.
CVI and VenoValve Explained:
What will I have to do?
Fill out our form
Fill out the pre-screener questionnaire above to see if you meet the basic qualifications.
Send your leg photos and get screened for eligibility
If you qualify with the pre-screener, you can share photos of your leg with the study team for additional screening and sign a consent form.
Once screening is complete, participants will be invited to take part in the study procedure. You can learn more about the specifics of the procedure at venovalve.com.
Frequently Asked Questions
CVI happens when the blood isn’t properly pumping up to the heart from the legs and begins to pool and cause issues such as varicose veins, swelling, skin color changes, pressure, pain, and in more severe forms, leg ulcers (sores).
With CVI, the reason the blood doesn’t always make it up to the heart is because of the valves in the veins not working properly. Think of these valves like a one-way door. They should open to let the blood up, and close behind the blood so it doesn’t fall back down. When the door swings both ways, allowing the blood to fall back down, the blood has a harder time making it all the way up. This means that not only will the blood build up causing pressure and swelling, it also won’t get the oxygen it needs from the heart.
Researchers are conducting this study to ensure that this treatment is safe and effective in participants with severe, deep venous CVI.
The current treatment options for this condition attempt to treat the symptoms of CVI, as opposed to the cause of the problem: malfunctioning valves inside the deep veins of the leg. The VenoValve® is a replacement valve that is implanted into the deep veins of the leg to restore proper blood flow.
Yes, there are some risks involved in this study, but steps are taken to minimize the likelihood and provide support if any adverse reactions occur. Any risks will be shared in further detail when participants receive the informed consent documents.
Yes! If you have the symptoms described you can go ahead and apply and if you pre-qualify, the study staff with do further screenings to determine if your symptoms are caused by CVI and if you are eligible for the study.
There is no monetary compensation for this study however the device, procedure, and related follow-up care are all provided at no cost.
If you are experiencing pain, swelling, pressure, skin changes or ulcers in one or both of your lower legs, you may qualify. Fill out the form on this page, and if you qualify through that, you will speak to a member of the study team who will further determine eligibility.
The participant will see their doctor for a year after the VenoValve® procedure, and then once a year for at least the next 4 years.
The participants will go through a screening period where personal health data is collected through a physical exam, and other study-related exams and activities. If participants are an ideal candidate, they can then have the VenoValve® device implanted. Appointments with the study team will happen regularly post operation to monitor the implanted device and provide study-related care.
No. Human trials have been done in several participants in Colombia with positive results, and no device-related safety issues. All endpoints demonstrated significant improvements in the participants. You can learn more about this previous study at venovalve.com.
There are 2.4 million people just in the U.S. with CVI, and there is no current cure for this painful condition. What is available for those with CVI at the moment is purely symptom management including elevating legs, compression socks and tights, and wound care for ulcers.
All costs related to the study are paid for by the sponsor.
The study doctor and some members of the study team will be able to see your health information and it will be used for the purpose of this study ONLY.
Yes. Your decision to be a part of this study is entirely voluntary and can be ended at any time.
* The VenoValve® is an investigational device that has not been approved by the FDA and is currently being evaluated for safety and effectiveness for the treatment of chronic venous insufficiency.