Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT04524793
Eligibility Criteria:
Inclusion Criteria:
* Age \>21 years, able to understand the requirements of the study and provide informed consent.
* C2 - C5 varicose veins / CVI
* Symptomatic primary GSV, SSV or AASV incompetence, with reflux \>0.5 seconds on colour duplex, including one or more of the following symptoms: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling.
* Patients who has GSV, SSV AASV diameters of 3mm to 12mm in the standing postition.
Exclusion Criteria:
* Current DVT or history of DVT
* Recurrent varicose veins
* Pregnant patients
* Arterial disease (ABPI \<0.8)
* Sepsis
* Patients who are unwilling to participate
* Inability or unwillingness to complete questionnaires
* Adverse reaction to sclerosant or cyanoacrylate
* GSV, SSV or AASV severely tortuous
* Life expectancy \< 1 year
* Active treatment for malignancy other than non-melanoma skin cancer
* Current, regular use of systemic anticoagulation (e.g. warfarin, heparin)
* Daily us of narcotic analgesia or NSAIDS to control pain associated with venous disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
99 Years
Study:
NCT04524793
Study Brief:
Protocol Section:
NCT04524793