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

Primary Purpose

Varicose Veins of Lower Limb

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ultrasound guided functional remodeling of lower extremity superficial vein valve
Sponsored by
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Veins of Lower Limb focused on measuring Varicose veins in the lower extremities, Ultrasonic guidance, venous valve of Lower limb

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-80, gender unlimited CEAP grading was C2-C5 patients The patient was clinically diagnosed as a primary varicose great saphenous vein of lower extremity, and the ultrasound findings were great saphenous vein valve insufficiency (complete structure, normal shape, enlarged valve ring, Duration of reflux >0.5s), only unilateral varicose great saphenous vein was treated this time Exclusion Criteria: Patients with target vessel diameter < 3mm The final valve of the great saphenous vein was not clear or lost its normal shape on ultrasound Patients with deep vein valvular insufficiency The presence of thrombus or thrombophlebitis in the main trunk of great cryptic skin Target diseased blood vessel had previously received surgical treatment Patients with deep vein thrombosis or history of pulmonary distension embolism Patients with active implants such as pacemakers or ICDs Patients with severe abnormal liver and kidney function (more than three times the normal value) Patients with non-primary varicose veins caused by post-deep vein thrombosis syndrome, Cockett syndrome (iliac vein compression syndrome), KT syndrome (venous malformation hypertrophy syndrome >, arteriovenous sputum, etc Any serious or uncontrolled systemic disease (including poorly medicated hypertension, diabetes, and diseases with active bleeding signs or severe coagulopathy) Patients with diseases that may make treatment and evaluation difficult (e.g., malignant arsine tumor, acute infectious diseases, sepsis, systemic intolerability of surgery, life expectancy less than 12 months, etc.) Pregnant and lactating women, or those who planned to have children during the study period Patients who have participated in clinical trials of other drugs or medical devices within the last 3 months Anesthetist and other patients were deemed unsuitable for the study

Sites / Locations

  • The Fourth Affiliated Hospital Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Venous valve remodeling

Arm Description

Venous valve function was remodeled under ultrasound guidance

Outcomes

Primary Outcome Measures

Venous valve regurgitation or not
Under the calf compression test, the venous valves were observed for blood flow regurgitation signal
Venous valve regurgitation or not
Under the calf compression test, the venous valves were observed for blood flow regurgitation signal
Venous valve regurgitation or not
Under the calf compression test, the venous valves were observed for blood flow regurgitation signal
Venous valve regurgitation or not
Under the calf compression test, the venous valves were observed for blood flow regurgitation signal
Venous valve regurgitation or not
Under the calf compression test, the venous valves were observed for blood flow regurgitation signal
Venous valve regurgitation or not
Under the calf compression test, the venous valves were observed for blood flow regurgitation signal
Changes in the duration of venous valve regurgitation
The duration of venous valve regurgitation was measured under calf compression test
Changes in the duration of venous valve regurgitation
The duration of venous valve regurgitation was measured under calf compression test
Changes in the duration of venous valve regurgitation
The duration of venous valve regurgitation was measured under calf compression test
Changes in the duration of venous valve regurgitation
The duration of venous valve regurgitation was measured under calf compression test
Changes in the duration of venous valve regurgitation
The duration of venous valve regurgitation was measured under calf compression test
Changes in the duration of venous valve regurgitation
The duration of venous valve regurgitation was measured under calf compression test

Secondary Outcome Measures

Full Information

First Posted
May 24, 2023
Last Updated
June 19, 2023
Sponsor
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05914740
Brief Title
Feasibility Study of Ultrasound-guided Functional Remodeling of Lower Extremity Superficial Venous Valve
Official Title
Feasibility Study of Ultrasound-guided Functional Remodeling of Lower Extremity Superficial Venous Valve
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Fourth Affiliated Hospital of Zhejiang University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins of Lower Limb
Keywords
Varicose veins in the lower extremities, Ultrasonic guidance, venous valve of Lower limb

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model 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 reconstructed in situ under ultrasound guidance. Postoperative ultrasound was used to assess venous valve function and complications in the operative area.
Masking
None (Open Label)
Masking Description
Open trial
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Venous valve remodeling
Arm Type
Experimental
Arm Description
Venous valve function was remodeled under ultrasound guidance
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided functional remodeling of lower extremity superficial vein valve
Intervention Description
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.
Primary Outcome Measure Information:
Title
Venous valve regurgitation or not
Description
Under the calf compression test, the venous valves were observed for blood flow regurgitation signal
Time Frame
immediately after intervention
Title
Venous valve regurgitation or not
Description
Under the calf compression test, the venous valves were observed for blood flow regurgitation signal
Time Frame
1 week after intervention
Title
Venous valve regurgitation or not
Description
Under the calf compression test, the venous valves were observed for blood flow regurgitation signal
Time Frame
1 month after intervention
Title
Venous valve regurgitation or not
Description
Under the calf compression test, the venous valves were observed for blood flow regurgitation signal
Time Frame
3 months after intervention
Title
Venous valve regurgitation or not
Description
Under the calf compression test, the venous valves were observed for blood flow regurgitation signal
Time Frame
6 months after intervention
Title
Venous valve regurgitation or not
Description
Under the calf compression test, the venous valves were observed for blood flow regurgitation signal
Time Frame
1 year after intervention
Title
Changes in the duration of venous valve regurgitation
Description
The duration of venous valve regurgitation was measured under calf compression test
Time Frame
immediately after intervention
Title
Changes in the duration of venous valve regurgitation
Description
The duration of venous valve regurgitation was measured under calf compression test
Time Frame
1 week after intervention
Title
Changes in the duration of venous valve regurgitation
Description
The duration of venous valve regurgitation was measured under calf compression test
Time Frame
1 month after intervention
Title
Changes in the duration of venous valve regurgitation
Description
The duration of venous valve regurgitation was measured under calf compression test
Time Frame
3 months after intervention
Title
Changes in the duration of venous valve regurgitation
Description
The duration of venous valve regurgitation was measured under calf compression test
Time Frame
6 months after intervention
Title
Changes in the duration of venous valve regurgitation
Description
The duration of venous valve regurgitation was measured under calf compression test
Time Frame
1 year after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-80, gender unlimited CEAP grading was C2-C5 patients The patient was clinically diagnosed as a primary varicose great saphenous vein of lower extremity, and the ultrasound findings were great saphenous vein valve insufficiency (complete structure, normal shape, enlarged valve ring, Duration of reflux >0.5s), only unilateral varicose great saphenous vein was treated this time Exclusion Criteria: Patients with target vessel diameter < 3mm The final valve of the great saphenous vein was not clear or lost its normal shape on ultrasound Patients with deep vein valvular insufficiency The presence of thrombus or thrombophlebitis in the main trunk of great cryptic skin Target diseased blood vessel had previously received surgical treatment Patients with deep vein thrombosis or history of pulmonary distension embolism Patients with active implants such as pacemakers or ICDs Patients with severe abnormal liver and kidney function (more than three times the normal value) Patients with non-primary varicose veins caused by post-deep vein thrombosis syndrome, Cockett syndrome (iliac vein compression syndrome), KT syndrome (venous malformation hypertrophy syndrome >, arteriovenous sputum, etc Any serious or uncontrolled systemic disease (including poorly medicated hypertension, diabetes, and diseases with active bleeding signs or severe coagulopathy) Patients with diseases that may make treatment and evaluation difficult (e.g., malignant arsine tumor, acute infectious diseases, sepsis, systemic intolerability of surgery, life expectancy less than 12 months, etc.) Pregnant and lactating women, or those who planned to have children during the study period Patients who have participated in clinical trials of other drugs or medical devices within the last 3 months Anesthetist and other patients were deemed unsuitable for the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuefeng Zhu, Master's
Phone
13868101010
Email
zhuyuefeng@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuefeng Zhu, Master's
Organizational Affiliation
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
The Fourth Affiliated Hospital Zhejiang University School of Medicine
City
Yiwu
State/Province
Zhejiang Procince
ZIP/Postal Code
322000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuefeng Zhu
Phone
13868101010
Email
srrshzyf@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35027279
Citation
De Maeseneer MG, Kakkos SK, Aherne T, Baekgaard N, Black S, Blomgren L, Giannoukas A, Gohel M, de Graaf R, Hamel-Desnos C, Jawien A, Jaworucka-Kaczorowska A, Lattimer CR, Mosti G, Noppeney T, van Rijn MJ, Stansby G, Esvs Guidelines Committee, Kolh P, Bastos Goncalves F, Chakfe N, Coscas R, de Borst GJ, Dias NV, Hinchliffe RJ, Koncar IB, Lindholt JS, Trimarchi S, Tulamo R, Twine CP, Vermassen F, Wanhainen A, Document Reviewers, Bjorck M, Labropoulos N, Lurie F, Mansilha A, Nyamekye IK, Ramirez Ortega M, Ulloa JH, Urbanek T, van Rij AM, Vuylsteke ME. Editor's Choice - European Society for Vascular Surgery (ESVS) 2022 Clinical Practice Guidelines on the Management of Chronic Venous Disease of the Lower Limbs. Eur J Vasc Endovasc Surg. 2022 Feb;63(2):184-267. doi: 10.1016/j.ejvs.2021.12.024. Epub 2022 Jan 11. No abstract available. Erratum In: Eur J Vasc Endovasc Surg. 2022 Aug-Sep;64(2-3):284-285.
Results Reference
result
PubMed Identifier
33990156
Citation
Muhlberger D, Brenner E, Frings N, Geier B, Mumme A, Reich-Schupke S, Steffen HP, Stenger D, Stucker M, Hummel T. Functional repair of the great saphenous vein by external valvuloplasty reduces the vein's diameter: 6-month results of a multicentre study. J Int Med Res. 2021 May;49(5):3000605211014364. doi: 10.1177/03000605211014364.
Results Reference
result

Learn more about this trial

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

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