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ACOART RF CLOSURE:Radiofrequency for Varicose Veins of Lower Extremity in China

NCT04658901 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2022-08-18

No results posted yet for this study

Summary

The purpose of the RCT trial is to determine whether endovenous radiofrequency closure catheter and endovenous radiofrequency closure generator is not inferior to ClosureFast™ and ClosureRFG™ in treating varicose veins of lower extremity.

Conditions

  • Varicose Veins of Lower Limb

Interventions

DEVICE

ERA-C70,ERA-C30 and ERA-G5

use endovenous radiofrequency closure catheter (ERA-C70,ERA-C30) and endovenous radiofrequency closure generator (ERA-G5) to treat varicose veins of lower extremity

DEVICE

ClosureFast™ and ClosureRFG™

use ClosureFast™ and ClosureRFG™ which has the indication of the treatment of varicose veins of lower extremity approved by NMPA

Sponsors & Collaborators

  • Zhejiang University

    collaborator OTHER

  • Acotec Scientific Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Hongkun Zhang, MD · Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-18
Primary Completion
2022-01-01
Completion
2022-04-12

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04658901 on ClinicalTrials.gov