search
Back to results

Endovenous Radiofrequency Ablation Closure System in the Treatment of Varicose Veins

Primary Purpose

Varicose Veins

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
radiofrequency ablation
Sponsored by
Suzhou Hengruihongyuan Medical Technology Co. LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Veins

Eligibility Criteria

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

Inclusion Criteria:

  1. Age 18-80 years old, no gender limit.
  2. Great saphenous varicose, CEAP grade C2-C6.
  3. The diameter of the diseased vein is ≥2mm, ≤15mm.
  4. Expected survival period ≥ 6 months.
  5. The informed consent form can be signed by the patient or the legal representative.

Exclusion Criteria:

  1. Are pregnant or breastfeeding.
  2. Participating in clinical trials of other devices or drugs.
  3. Deep vein thrombosis in the affected limb.
  4. Uncorrectable coagulation dysfunction and obvious abnormal blood picture, with obvious bleeding tendency (platelets≤30x109/L).
  5. Acute thrombosis in the main saphenous vein of the affected limb.
  6. The investigator judged that it is not suitable to participate in the clinical trial.

Sites / Locations

  • Zhongshan Hospital
  • Affiliated Hangzhou First People's Hospital ,Zhejiang University School of Medicine
  • ZheJiang Provincial People's Hospital
  • The Fourth Affiliated Hospital ,Zhejiang University School of Medicine
  • The Second Affiliated Hospital of Zhejiang University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endovenous Radiofrequency Ablation Closure System

ClosureFast™ Radiofrequency Ablation System

Arm Description

Outcomes

Primary Outcome Measures

Vascular closure rate at 6 months after the operation
Calculation method: completely closed patients / total cases of subjects in the same group x 100%. Definition of complete closure: Complete closure refers to ultrasound follow-up at 6 months after surgery that shows no blood flow in varicose veins.

Secondary Outcome Measures

CEAP
The CEAP is an elaborate scoring system for varicose veins and other disorders from venous insufficiency. It has been developed to determine the severity of the condition for diagnosis and treatment point of view. CEAP stands for: Clinical Etiopathological Anatomical Pathophysiological
Technical success rate
The device is delivered in place and withdrawn smoothly, and the target diseased blood vessel is immediately examined by ultrasound without blood flow.
Evaluation of the use of devices
For endovenous radiofrequency closure catheter: evaluation on the degree of device flexibility, crossability, accuracy, usability (subjective evaluation scale: excellent, good and poor) For endovenous radiofrequency closure generator: evaluation on applicability,accuracy of identifying catheter version, stability in the procedure(subjective evaluation: yes or no)
VCSS
Changes from baseline in venous clinical severity score (VCSS) (0-30, higher scores mean a worse outcome) in outpatient services. the VCSS was derived by the American Venous Forum from the CEAP classification and provides means by which clinical outcomes in venous disease can be monitored in time.Compared to the CEAP, VCSS is said to be more responsive to changes in disease severity, thus making it great for progressive rankings. It proved good inter and intra observer reproducibility and is often cited in quality of life assessments

Full Information

First Posted
December 10, 2020
Last Updated
September 22, 2021
Sponsor
Suzhou Hengruihongyuan Medical Technology Co. LTD
search

1. Study Identification

Unique Protocol Identification Number
NCT04671641
Brief Title
Endovenous Radiofrequency Ablation Closure System in the Treatment of Varicose Veins
Official Title
Prospective, Multi-center, Randomized Controlled Study to Evaluate the Effectiveness and Safety of Endovenous Radiofrequency Ablation Closure System in the Treatment of Varicose Veins
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
July 2, 2022 (Anticipated)
Study Completion Date
October 2, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Hengruihongyuan Medical Technology Co. LTD

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
The goal of this clinical trial is to evaluate the effectiveness and safety of the endovenous radiofrequency ablation closure system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. for the treatment of varicose veins.
Detailed Description
In this prospective, multi-center, randomized controlled study, 176 patients who were diagnosed with varicose veins and met the inclusion criteria without any exclusion criteria were randomly divided into the experimental group (Hongyuan Endovenous Radiofrequency Ablation Closure System)and control group (Medtronic's ClosureFast™ Radiofrequency Ablation System) at 1:1. The effectiveness of the product was evaluated by the vascular closure rate at 6 months after the operation, and the safety of the product was evaluated by the incidence of adverse events and serious adverse events within 6 months after the operation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
176 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endovenous Radiofrequency Ablation Closure System
Arm Type
Experimental
Arm Title
ClosureFast™ Radiofrequency Ablation System
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
radiofrequency ablation
Intervention Description
ultrasound-guided radiofrequency ablation is performed to treat varicose veins patients
Primary Outcome Measure Information:
Title
Vascular closure rate at 6 months after the operation
Description
Calculation method: completely closed patients / total cases of subjects in the same group x 100%. Definition of complete closure: Complete closure refers to ultrasound follow-up at 6 months after surgery that shows no blood flow in varicose veins.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
CEAP
Description
The CEAP is an elaborate scoring system for varicose veins and other disorders from venous insufficiency. It has been developed to determine the severity of the condition for diagnosis and treatment point of view. CEAP stands for: Clinical Etiopathological Anatomical Pathophysiological
Time Frame
6 months
Title
Technical success rate
Description
The device is delivered in place and withdrawn smoothly, and the target diseased blood vessel is immediately examined by ultrasound without blood flow.
Time Frame
6 months
Title
Evaluation of the use of devices
Description
For endovenous radiofrequency closure catheter: evaluation on the degree of device flexibility, crossability, accuracy, usability (subjective evaluation scale: excellent, good and poor) For endovenous radiofrequency closure generator: evaluation on applicability,accuracy of identifying catheter version, stability in the procedure(subjective evaluation: yes or no)
Time Frame
6 months
Title
VCSS
Description
Changes from baseline in venous clinical severity score (VCSS) (0-30, higher scores mean a worse outcome) in outpatient services. the VCSS was derived by the American Venous Forum from the CEAP classification and provides means by which clinical outcomes in venous disease can be monitored in time.Compared to the CEAP, VCSS is said to be more responsive to changes in disease severity, thus making it great for progressive rankings. It proved good inter and intra observer reproducibility and is often cited in quality of life assessments
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Rate of serious adverse events within 6 months after surgery
Time Frame
6 months
Title
Rate of adverse events within 6 months after surgery
Time Frame
6 months

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 years old, no gender limit. Great saphenous varicose, CEAP grade C2-C6. The diameter of the diseased vein is ≥2mm, ≤15mm. Expected survival period ≥ 6 months. The informed consent form can be signed by the patient or the legal representative. Exclusion Criteria: Are pregnant or breastfeeding. Participating in clinical trials of other devices or drugs. Deep vein thrombosis in the affected limb. Uncorrectable coagulation dysfunction and obvious abnormal blood picture, with obvious bleeding tendency (platelets≤30x109/L). Acute thrombosis in the main saphenous vein of the affected limb. The investigator judged that it is not suitable to participate in the clinical trial.
Facility Information:
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Affiliated Hangzhou First People's Hospital ,Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Name
ZheJiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Facility Name
The Fourth Affiliated Hospital ,Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310052
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
322000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Endovenous Radiofrequency Ablation Closure System in the Treatment of Varicose Veins

We'll reach out to this number within 24 hrs