Your session is about to expire
← Back to Search
VenoValve® Implant for Venous Insufficiency
Study Summary
This trial is looking at a new valve that can be implanted in people with a specific type of heart valve problem. The aim is to see if it is safe and effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- You regularly use strong pain medications for a long time.My blood flow through arteries in my legs is significantly reduced.I have a stent in the vein of my thigh or knee area.I have tried standard treatments like compression therapy for over 3 months without success.I am 18 years old or older.The blood takes too long to flow through a specific vein in your leg.I have an active cancer other than non-melanoma skin cancer.You can handle having a duplex ultrasound.You weigh less than 40 kilograms for every meter of your height.You have a CEAP score of C4b, C4c, C5, or C6.I have a negative COVID-19 test taken within the last 6 days or I am fully vaccinated.I agree to use birth control from the start to the end of the study.I have superficial vein reflux.I am a woman who can have children and have a recent negative pregnancy test.My vein for the procedure is at least 8 mm wide.I have a blood clotting disorder that can't be managed with blood thinners.I have had minor vein procedures within the last 6 weeks.I had surgery before on the deep veins on one side of my body.You are allergic to stainless steel or pig tissue.You tested positive for COVID-19 in the last 3 months.I cannot take blood thinners due to health reasons.I have not had a blood clot in my legs or lungs in the last 30 days.My swelling is not caused by vein problems.I am not breastfeeding and do not plan to during the study.I have a vein inflammation near the skin's surface.I have a blockage in my iliac vein or inferior vena cava that is more than half blocked and hasn't been treated.You have too many platelets in your blood.My heart condition severely limits my physical activity.I can attend all follow-up appointments after treatment.I have a vein problem due to a clot or other causes.I have been diagnosed with fibromyalgia.I have severe blockage in the veins of my lower limbs.I can walk on my own without help.
- Group 1: VenoValve
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants are being administered treatment in this trial?
"Affirmative. The clinical trial is currently recruiting for a total of 75 participants across 25 sites, according to the information on clinicialtrials.gov - which was last modified on September 23rd 2022. It was initially posted on August 27th 2021."
How many medical centers are conducting this investigation?
"Presently, 25 medical clinics are conducting this trial in cities like Bellevue, Pittsburgh and Buffalo. To ensure minimal travel requirements if you decide to participate, it is recommended that you select the clinic closest to your residence."
Is enrollment for this experiment still accepting participants?
"Indeed, the clinicaltrials.gov portal confirms that this study is actively recruiting participants. The trial was first published on August 27th 2021 and has been recently updated to reflect its need for 75 participants at 25 sites across America."
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
Share this study with friends
Copy Link
Messenger