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A long-term follow-up study of a prospective, multi-center, randomized, controlled clinical trial evaluating the safety and efficacy of a kit for sealing varicose veins (formerly known as the Varicose Vein Sealing System) for the treatment of varicose veins in the lower extremities.

A long-term follow-up study of a prospective, multi-center, randomized, controlled clinical trial evaluating the safety and efficacy of a kit for sealing varicose veins (formerly known as the Varicose Vein Sealing System) for the treatment of varicose veins in the lower extremities.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122406
Enrollment
Unknown
Registered
2026-04-13
Start date
2024-10-17
Completion date
Unknown
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicose great saphenous veins of lower extremities (limited to superficial veins)

Interventions

Experimental group :The treatment was carried out using the varicose vein sealing kit produced by Shanghai Yishimiao Medical Devices Co., Ltd. (formerly known as the Varicose Vein Sealing System)
Control group :The treatment was performed using the intracavity radiofrequency closure generator ClosureRFGTM and the intracavity radiofrequency closure catheter ClosureFastTM manufactured by Medtron

Sponsors

Shanghai Changzheng Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: This study is expected to enroll all subjects selected for the 'A prospective, multicenter, randomized, controlled clinical trial to verify the safety and efficacy of varicose closure systems for the varicose veins in lower extremities'

Exclusion criteria

Exclusion criteria: 1. The subject requests to withdraw; 2. The researcher determines that the subject is not suitable to continue participating in the study.

Design outcomes

Primary

MeasureTime frame
The complete closure rate of the great saphenous vein at 24 months, 36 months, 48 months and 60 months after the operation;Venous clinical severity score (VCSS) at 24 months, 36 months, 48 months and 60 months after the operation;The Abertine Varicose Veins Questionnaire (AVVQ) scores at 24 months, 36 months, 48 months, and 60 months after the surgery;—

Countries

China

Contacts

Public ContactQu Lefeng

Shanghai Changzheng Hospital

Qulefeng@163.com+86 186 1650 5267

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026