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New study tests vein treatment in patients over 80
NCT ID NCT07233616
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to see if a common vein treatment called radiofrequency ablation is safe and helpful for people aged 80 and older with severe chronic venous insufficiency. About 50 participants will receive the procedure and be followed for 6 months. The goal is to measure how well the treated veins close and how much leg symptoms improve.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population consists of patients aged 80 years and older who are diagnosed with symptomatic, severe chronic venous insufficiency (CVI), classified as CEAP clinical classes C3 through C6, and have confirmed great or small saphenous vein reflux.
- Ages
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80 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age: Aged 80 years or older. 2. Clinical Diagnosis: Symptomatic chronic venous insufficiency of the lower extremity, with the highest clinical class (CEAP classification) being one of the following: * C3: Venous edema * C4a: Pigmentation or eczema * C4b: Lipodermatosclerosis or atrophie blanche * C5: Healed venous ulcer * C6: Active venous ulcer 3. Confirmed Reflux: Color duplex ultrasound examination confirming reflux (reflux time \> 0.5 seconds) in the great saphenous vein (GSV) and/or small saphenous vein (SSV) of the target limb. 4. Informed Consent: The patient or their legally authorized representative is able to understand and voluntarily provides written informed consent. Exclusion Criteria: * Participants who meet any of the following criteria will be excluded from the study: 1. Mobility: Non-ambulatory or bedridden. 2. Thrombosis: Presence of acute superficial thrombophlebitis of the target vein, or deep vein thrombosis (DVT) in the target limb. 3. Arterial Disease: Significant peripheral arterial disease, defined as an ankle-brachial index (ABI) \< 0.8 in the target limb. 4. Coagulopathy: Uncorrectable coagulation disorder. 5. Allergy: Known severe allergy to local anesthetics (e.g., lidocaine) or relevant device materials. 6. Cognition \& Compliance: Severe cognitive impairment or psychiatric illness that, in the investigator's judgment, precludes adequate understanding and cooperation for the study procedures and follow-up. 7. Life Expectancy: Life expectancy of less than 1 year due to other comorbid conditions (e.g., terminal malignancy). 8. General Unsuitability: Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital of Chengdu University of Traditional Chinese Medicine
RECRUITINGChengdu, Sichuan, 610072, China
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