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Chronic Venous Insufficiency, CVINCT07233616

Risks and Benefits of Radiofrequency Ablation for Chronic Venous Insufficiency (CEAP C3-C6) in Patients Aged 80 and Over

An observational study of Chronic Venous Insufficiency, CVI and Radiofrequency Ablation, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The prevalence of severe chronic venous insufficiency (CVI) is significant in the growing octogenarian population. While radiofrequency ablation (RFA) is a standard minimally invasive treatment, robust data on its outcomes and safety profiles specifically in patients aged 80 years and older remain scarce. Read more about this study

Who is it for?
Ages 80 years and older
What is being tested?
Endovenous Radiofrequency Ablation
Type of treatment
Surgery or procedure
How many people
50 participants
Where
1 siteChina
Study dates
1 Oct 2025to 1 Sep 2026
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 80 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: 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.

Who may be able to join

  • Age: Aged 80 years or older.
  • 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
Show all 9Show fewer
  • C6: Active venous ulcer
  • 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.
  • Informed Consent: The patient or their legally authorized representative is able to understand and voluntarily provides written informed consent.

Who cannot join

  • Participants who meet any of the following criteria will be excluded from the study:
  • Mobility: Non-ambulatory or bedridden.
  • Thrombosis: Presence of acute superficial thrombophlebitis of the target vein, or deep vein thrombosis (DVT) in the target limb.
  • Arterial Disease: Significant peripheral arterial disease, defined as an ankle-brachial index (ABI) < 0.8 in the target limb.
  • Coagulopathy: Uncorrectable coagulation disorder.
  • Allergy: Known severe allergy to local anesthetics (e.g., lidocaine) or relevant device materials.
Show all 9Show fewer
  • 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.
  • Life Expectancy: Life expectancy of less than 1 year due to other comorbid conditions (e.g., terminal malignancy).
  • General Unsuitability: Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chunshui He Doctor contact

18981885601

Chunshuihe@msn.com

China1 site, 1 recruiting

  • Hospital of Chengdu University of Traditional Chinese Medicine

    Chengdu, Sichuan, 610072

    Chunshui He Doctor, 18981885601, zhanghq@stu.cdutcm.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Risks and Benefits of Radiofrequency Ablation for Chronic Venous Insufficiency (CEAP C3-C6) in Patients Aged 80 and Over: A Prospective Single-Arm Cohort Study

The prevalence of severe chronic venous insufficiency (CVI) is significant in the growing octogenarian population. While radiofrequency ablation (RFA) is a standard minimally invasive treatment, robust data on its outcomes and safety profiles specifically in patients aged 80 years and older remain scarce. This study aims to evaluate the risks and benefits of RFA in this specific, high-risk demographic.This prospective, single-arm, single-center cohort study will enroll 50 patients (initial target sample size) aged ≥80 years with CVI classified as CEAP C3 to C6 and with confirmed great or small saphenous vein reflux. All participants will undergo endovenous RFA under tumescent local anesthesia. The primary outcomes are: 1) the great/small saphenous vein occlusion rate at 6 months, assessed by duplex ultrasonography, and 2) the change in disease-specific quality of life from baseline to 6 months, measured by the Aberdeen Varicose Vein Questionnaire (AVVQ). Secondary outcomes include occlusion rates at 1 and 3 months; complication rates (e.g., deep vein thrombosis, skin burns, paresthesia) within 30 days; and changes in the Venous Clinical Severity Score (VCSS) and the 12-Item Short Form Health Survey (SF-12) at predefined intervals over 6 months.This study is designed to demonstrate a high technical success rate (occlusion rate >95% at 6 months) and a statistically significant improvement in AVVQ and VCSS scores at 6 months post-procedure. The collected data will provide a detailed profile of complication rates, characterizing the safety of RFA in this very elderly cohort.This study will provide crucial, prospective evidence regarding the efficacy and safety of RFA for treating CVI in octogenarians. The findings are expected to guide clinical decision-making and inform treatment guidelines for this vulnerable and expanding patient population.

Being tested
Endovenous Radiofrequency Ablation
Medical subject headings
Blindness, Cortical

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endovenous Radiofrequency AblationProcedure or surgery

    All patients undergo endovenous radiofrequency ablation(RFA) under local tumescent anesthesia. Using the ClosureFast™ system (or equivalent), the target saphenous vein is accessed percutaneously under ultrasound guidance. After catheter placement and tumescent anesthesia infiltration, radiofrequency energy is delivered segmentally to ablate the vein. Post-procedure, compression bandaging is applied and Class II compression stockings are prescribed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Great/Small Saphenous Vein Occlusion Rate at 6 Months

    Measured: 6 Months

  2. Aberdeen Varicose Vein Questionnaire (AVVQ)

    Minimum Score: 0 Maximum Score: 100 Interpretation of Higher Scores: A higher score indicates more severe symptom distress and greater impact on quality of life caused by varicose veins in patients. For example, it reflects more obvious discomforts such as leg pain, a heavy sensation in the legs, and swelling.

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2025
  2. Study start1 Oct 2025
  3. Primary completion30 May 2026 (estimated)
  4. Study completion1 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07233616
Sponsor's protocol ID
ChengduUTCM 121
Status last verified
Sep 2025
First submitted
28 Sep 2025
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kulkarni SR, Slim FJ, Emerson LG, Davies C, Bulbulia RA, Whyman MR, Poskitt KR. Effect of foam sclerotherapy on healing and long-term recurrence in chronic venous leg ulcers. Phlebology. 2013 Apr;28(3):140-6. doi: 10.1258/phleb.2011.011118.

    PubMed 22422794

  • Williamsson C, Danielsson P, Smith L. Catheter-directed foam sclerotherapy for chronic venous leg ulcers. Phlebology. 2014 Dec;29(10):688-93. doi: 10.1177/0268355513505506. Epub 2013 Sep 26.

    PubMed 24072751

  • Mohamed AH, Howitt A, Rae S, Cai PL, Hitchman L, Wallace T, Nandhra S, Pymer S, Knighton A, Smith G, Chetter IC, Carradice D. Ten-year outcomes of a randomized clinical trial of endothermal ablation versus conventional surgery for great saphenous varicose veins. Br J Surg. 2024 Aug 2;111(8):znae195. doi: 10.1093/bjs/znae195.

    PubMed 39162334

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Venous Insufficiency, CVI and Radiofrequency Ablation, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chunshui He Doctor (18981885601, Chunshuihe@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Great/Small Saphenous Vein Occlusion Rate at 6 Months (time frame: 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07233616, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.

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