Radiofrequency ablation using Closure fast
ProcedureThermal ablation technique
Other names: Laserablation using laser fiber
NCT Number: NCT06318988
This study aims to describe conservative and invasive treatments for patients with chronic venous disease (CVD) in Belgium, and their association with clinical and patient-reported outcomes during a follow-up of 24 months.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
This study is an observational, prospective, multicentre study to assess the effectiveness of conservative and invasive treatments in patients with CVD in Belgium. The inclusion period of the study will last 6 months. Patients will be followed until 2 years after inclusion into the study.
During the inclusion period, after confirmation of eligibility, patients with CVD diagnosed by the General Practitioner (GP) and requiring a treatment will be invited to participate in the study. About 140 GPs across Belgium will be included in the study. During the first visit, a treatment strategy will be proposed to the patient by the GP. The treatment can be conservative or invasive, depending on the severity of the disease. Patients awaiting invasive treatment may receive conservative treatment to alleviate symptoms. The choice of treatment modality is left to the discretion of the treating physician, in agreement with the patient and according to local policies. As this is an observational study, there will be no interference in the choice of treatment, and no restrictions will be imposed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Thermal ablation technique
Other names: Laserablation using laser fiber
sclero-or foamsclerose
Other names: polidocanol
Venoactive drugs
Other names: Venoruton, Antistax
Compression
Time frame: baseline to 12 weeks
Chronic Venous Insufficiency QOL questionnaire-20 score, min 20 max 100, higher means worse outcome
Time frame: month 24
Proportion of patients who received an intervention as secondary/add-on treatment to conservative treatment
Time frame: through study completion, an average of 2 years
The change in the CIVIQ-20 over time; min 20 max 100, higher means worse outcome
Time frame: through study completion, an average of 2 years
The change in the clinical part of the CEAP classification over time, min C0, max C6, higher means worse outcome
Time frame: through study completion, an average of 2 years
The change in the rVCSS over time; min 0 max 30, higher means worse outcome
Time frame: through study completion, an average of 2 years
The change in the symptomatology over time, recorded with a questionnaire
Time frame: through study completion, an average of 2 years
The change in satisfaction score over time, min 0, max 10; higher means better outcome
Time frame: month 24
Number and proportion of patients with Adverse Events (AEs).
Contact information is provided by the study sponsor or research team.
Universitaire Ziekenhuizen KU Leuven
Other
An Observational, Prospective Study to Assess the Outcomes of Different Treatment Options in Patients With Chronic Venous Disease in Belgium
Acronym: VOS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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