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Great Saphenous Vein Sparing Segmental Radiofrequency Ablation in Varicose Veins Patients

NCT05372146 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2022-05-19

No results posted yet for this study

Summary

86 patients were randomized into hot-CHIVA (n=43) and control (n=43) groups. Study group patients had undergone radiofrequency ablation (RFA) VNUS Closure - FastTM of one segment of GSV close to saphenofemoral junction. Controls had undergone whole refluxing trunk ablation. Additional phlebectomy was performed in all the patients of both groups. Primary end-point was change in quality of life (QoL) measured with CIVIQ-20 at 12 months. Secondary end-points was recurrence of varicose veins at 12 months. The investigators also measured GSV caliber at the median and distal thigh change in hot-CHIVA group.

Conditions

  • Varicose Veins
  • Varicose Veins of Lower Limb

Interventions

PROCEDURE

GSV radiofrequency ablation with concomitant phlebectomy

Radiofrequency ablation with concomitant phlebectomy

Sponsors & Collaborators

  • Pirogov Russian National Research Medical University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2020-09-01
Completion
2022-02-27

Countries

  • Russia

Study Locations

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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 NCT05372146 on ClinicalTrials.gov