NCT05914740

Feasibility Study of Ultrasound-guided Functional Remodeling of Lower Extremity Superficial Venous Valve

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In this project, an exploratory study was conducted to perform in situ venous valve remodeling in vivo, evaluate venous valve function after surgery and conduct regular follow-up, collect relevant ultrasonic data before, during and after surgery, and evaluate the safety and effectiveness of Ultrasound-guided percutaneous great saphenous vein valve functional remodeling.

Detailed description

A certain number of patients meeting the requirements (meeting the inclusion criteria, but not meeting the exclusion criteria) were selected for preoperative hemodynamic evaluation of lower extremity vein ultrasound to determine the reflux points and reflux points, identify the blood circulation pattern, and design an individualized surgical program. Intraoperative venous valve was remodeled in situ under ultrasound guidance. Postoperative ultrasound was used to assess venous valve function and complications in the operative area. Screening period (before surgery 14 days to 0 days) Subject signs informed consent. General information and previous medical history of subjects were collected, preoperative laboratory examination (blood routine, blood biochemistry, coagulation function, preoperative immunity, blood type), electrocardiogram, ultrasound, preoperative hemodynamic evaluation of lower extremity vein were completed, and evaluation scales such as CEAP grading, VCSS, AVVQ, CIVIQ and pain score were completed. Subjects who meet the inclusion criteria and do not meet all exclusion criteria will be admitted. Day of surgery (day 0) Preoperative ultrasound was re-evaluated to confirm the valve function, and the tissue was disinfected. Hyaluronic acid was injected around the valve of the great saphenous vein to rebuild the valve about 1-2ml, and the whole process was monitored under ultrasound. During the injection, the valve function was pumped back for protection, and the injection was performed multiple times at different points. Supplementary injection: Following the subject's voluntary principle, the researcher can give supplementary injection after evaluating the general condition of the subject. The follow-up period for each subject was 12 months ±20 days after enrollment. Follow-up period (±3 days at 1 week, ±5 days at 1 month, ±10 days at 3 months, ±15 days at 6 months, ±20 days at 1 year) General data of subjects were collected, laboratory examination (blood routine and blood biochemistry) and postoperative ultrasound hemodynamic evaluation of lower limb veins were improved, and evaluation scales such as VCSS, AVVQ, CIVIQ and pain score were completed. This study does not involve vulnerable groups.

Conditions

• Varicose Veins of Lower Limb

Interventions

Type	Name	Description
PROCEDURE	Ultrasound guided functional remodeling of lower extremity superficial vein valve	Preoperative ultrasound was used to re-evaluate and confirm the valve function, disinfect the tissue, inject hyaluronic acid around the great saphenous vein valve to reshape the valve about 1-2ml, monitor the whole process under ultrasound, pump back for protection during injection, and inject multiple times at different points.

Timeline

• Start date: 2023-04-19
• Primary completion: 2023-12-31
• Completion: 2024-07-30
• First posted: 2023-06-22
• Last updated: 2023-06-22

Locations

1 site across 1 country: China