Study Details
VenoValve: A Device for Patients with CVI
(IRB#: IRB_00146913)
Chronic Venous Insufficiency (CVI) is a severe condition that involves leg pain, leg swelling, enlarged veins, skin discoloration, and open sores on the lower legs. VenoValve® is a device that may resolve serious CVI symptoms. Scientists and doctors do not know the safety and effectiveness of this device. Research is needed to learn if it may be approved and used to improve the health of CVI patients
- All genders
- Over 18 years old
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: Over 18 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Ages 18 years and older
- Walk without help
- Attend follow-up visits
- Use specific birth control during the 5-year study
- Able to attend in person at the University of Utah
Exclusion Criteria
- Unable to use anticoagulation (blood thinner) medicines
- Active cancer except for skin cancer
- Positive COVID-19 test result within the last 3 months
- Sensitive to stainless steel or porcine tissue (having to do with swine, pigs, and pork).
Will I be paid for my time?
Yes
IRB#: IRB_00146913
PI: Claire Griffin
Department: Vascular Surgery Division
Approval Date: 2022-03-09 07:00:00
Study Categories: Heart Studies
Specialties: Vascular Surgery, Wound Care