Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Endovenous Radio Frequency (EVRF) for Treatment of Varicose Veins in Singapore (ESVS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04384315
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : September 27, 2021
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital

Brief Summary:
The aim of this study is to report a collaborative, prospective Singaporean experience using the Endovenous Radio Frequency® (EVRF®) from F Care Systems (Belgian) for the treatment of primary great and short saphenous vein reflux.

Condition or disease Intervention/treatment
Varicose Veins Venous Reflux Chronic Venous Insufficiency Other: Questionnaires

Detailed Description:
The investigators wish to evaluate its safety, efficacy, and performance. Although it has been shown to be safe and efficacious in its initial trials, these studies have been limited to generally a caucasian-based population, where the vein size, anatomy and distribution of venous incompetence can be different from their asian counterparts. The study will evaluate the technical, anatomical and clinical performance of EVRF® performed on multiple truncal varicose veins, and without mandatory postoperative compression stockings of the GSV, SSV or AASV. The two primary endpoints for this evaluation are technical success at the time of the procedure, and anatomical success, reported as complete closure at 2-weeks, 3 months, 6 months and 12 months.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study to Investigate the Efficacy and Safety of Endovenous Radio Frequency (EVRF) for Treatment of Varicose Veins in Singapore
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Group/Cohort Intervention/treatment
EVRF
Patients that have undergone Endovenous Radio Frequency® (EVRF®) from F Care Systems (Belgian) for the treatment of primary great and short saphenous vein reflux.
Other: Questionnaires
Questionnaires to assess the quality of life (EQ-5D, CVVQ, CIVIQ, AVVQ, Patient satisfaction survey)




Primary Outcome Measures :
  1. Technical Success at time of procedure [ Time Frame: Immediately post-procedure ]
    Occlusion of treated vein post-procedure

  2. Anatomical Success [ Time Frame: 2 weeks to 12 months post-procedure ]
    Anatomical success defined as occlusion of treated vessel, as determined by duplex ultrasound.


Secondary Outcome Measures :
  1. Quality of Life Score using the EQ-5D questionnaire [ Time Frame: 2 weeks, 3 months, 6 months, 12 months post-procedure ]
    EQ5D is used to assess quality of life based on Mobility, Self-Care, Usual Activities, Pain/Discomfort and Anxiety, rated at 5 levels: no problems, slight problems, moderate problems, severe problems, unable to perform activity. Inputs from this questionnaire is used to observe for changes in quality of life overtime.

  2. Quality of Life Score using the Chronic Venous Insufficiency Questionnaire (CIVIQ) [ Time Frame: 2 weeks, 3 months, 6 months, 12 months post-procedure ]
    CIVIQ is a questionnaire based on three dimensions - pain, physical and psychological, based on a scale from 1 to 5 (no trouble, slight, moderate, considerable, severe). Based on inputs, Global Index Score (GIS) will be tabulated, ranging for 0 to 100 - the higher the value, the poorer the quality of life.

  3. Quality of Life score using the Aberdeen Varicose Vein Questionnaire (AVVQ) [ Time Frame: 2 weeks, 3 months, 6 months, 12 months post-procedure ]
    To measure health status of varicose veins patients based on symptoms and impact on daily activities. A total score ranging from 0 to 100 will be tabulated, with 100 being worst quality of life

  4. Clinical Change using Venous Clinical Severity Score (VCSS) [ Time Frame: 2 weeks, 3 months, 6 months, 12 months post-procedure ]
    VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (mild), 2 (moderate), 3 (severe).

  5. Pain Score [ Time Frame: First 10 days post-operation ]
    Using a numerical rating scale, which ranges from 0 (no pain) to 10 (severe pain)

  6. Time taken to return to work and normal activities [ Time Frame: 10 days post-operation ]
  7. Occlusion rates [ Time Frame: 2 weeks, 3 months, 6 months, 12 months post-procedure ]
    Duplex ultrasound performed at specific timepoints to ensure that treated vein is occluded

  8. Patient satisfaction with treatment: survey [ Time Frame: 2 weeks, 3 months, 6 months, 12 months post-procedure ]
    A short survey to assess patient satisfaction and if there are any observed improvement in terms of appearance and symptoms post-procedure.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients who will be undergoing Endovenous Radio Frequency® (EVRF®) as a treatment for their varicose veins / chronic venous insufficiency
Criteria

Inclusion Criteria:

  1. Age >21 years, able to understand the requirements of the study and provide informed consent.
  2. C2 - C5 varicose veins / CVI
  3. Symptomatic primaryGSV, SSV or AASV incompetence, with reflux >0.5 seconds on colour duplex, including one or more of the following symptoms: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling.
  4. Patients who has GSV, SSV or AASV diameters of 3mm to 12mm in the standing position.

Exclusion Criteria:

  1. Current DVT or history of DVT
  2. Recurrent varicose veins
  3. Pregnant patients
  4. Arterial disease (ABPI<0.8)
  5. Sepsis
  6. Patients who are unwilling to participate
  7. Inability or unwillingness to complete questionnaires
  8. Adverse reaction to sclerosant or cyanoacrylate
  9. GSV, SSV or AASV severely tortuous
  10. Life expectancy < 1 year
  11. Active treatment for malignancy other than non-melanoma skin cancer
  12. Current, regular use of systemic anticoagulation (e.g. warfarin, heparin)
  13. Daily use of narcotic analgesia or NSAIDS to control pain associated with venous disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04384315


Contacts
Layout table for location contacts
Contact: Charyl Yap 65767986 charyl.yap.j.q@sgh.com.sg

Locations
Layout table for location information
Singapore
Singapre General Hospital Recruiting
Singapore, Singaopore, Singapore, 169608
Contact: Charyl Yap    65767986    charyl.yap.j.q@sgh.com.sg   
Principal Investigator: Tjun Yip Tang         
Sponsors and Collaborators
Singapore General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Tjun Yip Tang Singapore General Hospital
Publications:
Geza M, Gloviczki P. Venous Embryology and Anatomy. In: Bergan JJ, editor. The Vein Book: Elsivier Academic Press; 2007.

Layout table for additonal information
Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT04384315    
Other Study ID Numbers: 2019/2544
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: September 27, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Singapore General Hospital:
Endovenous Ablation
Additional relevant MeSH terms:
Layout table for MeSH terms
Venous Insufficiency
Varicose Veins
Vascular Diseases
Cardiovascular Diseases