NCT04524793

Brief Summary

The purpose of this study is to assess change in patient's symptoms before and after Endovenous Microwave Ablation (EMA) as treatment for varicose veins. At the same time, it is to evaluate the effectiveness of EMA and its treatment outcomes over a period of 1 year.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 24, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 27, 2021

Status Verified

September 1, 2021

Enrollment Period

1.1 years

First QC Date

August 12, 2020

Last Update Submit

September 23, 2021

Conditions

Venous InsufficiencyVaricose VeinsVascular Diseases

Keywords

endovenous microwave ablation

Outcome Measures

Primary Outcomes (2)

  • Technical Success at time of procedure

    Occlusion of treated vein post-procedure

    Immediately post-procedure

  • Anatomical Success

    Anatomical success defined as occlusion of treated vessel, as determined by duplex ultrasound

    2 weeks to 12 months post-procedure

Secondary Outcomes (8)

  • Quality of Life score using EQ-5D questionnaire

    Baseline, 2-weeks, 3 months, 6 months and 12 months

  • Quality of life score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)

    Baseline, 2-weeks, 3 months, 6 months and 12 months

  • Quality of life score using the Aberdeen Varicose Veins Questionnaire (AVVQ)

    Baseline, 2-weeks, 3 months, 6 months and 12 months

  • Clinical Change using Venous Clinical Severity Score (VCSS)

    Baseline, 2-weeks, 3 months, 6 months and 12 months

  • Time taken to return to work and normal activities

    10 days post-op

  • +3 more secondary outcomes

Study Arms (1)

Endovenous Microwave Ablations

OTHER

Patients that have undergone Endovenous Microwave Ablation from ECO (Nanjing ECO Microwave System Co., Ltd) to treat primary great and short saphenous vein reflux

Other: QuestionnairesOther: Physical examinations

Interventions

QuestionnairesOTHER

Questionnaires to assess the quality of life (EQ-5D, CVVQ, CIVIQ, AVVQ, Patient satisfaction survey)

Endovenous Microwave Ablations
Physical examinationsOTHER

GSV/SSV/AASV reflux, CEAP Classification (Clinical, Aetiological, Anatomical and Pathophysiology), Venous Clinical Severity Score (VCSS) and duplex ultrasound

Endovenous Microwave Ablations

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>21 years, able to understand the requirements of the study and provide informed consent.
  • C2 - C5 varicose veins / CVI
  • Symptomatic primary GSV, 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.
  • Patients who has GSV, SSV AASV diameters of 3mm to 12mm in the standing postition.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (7)

  • Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, Lohr JM, McLafferty RB, Meissner MH, Murad MH, Padberg FT, Pappas PJ, Passman MA, Raffetto JD, Vasquez MA, Wakefield TW; Society for Vascular Surgery; American Venous Forum. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011 May;53(5 Suppl):2S-48S. doi: 10.1016/j.jvs.2011.01.079.

    PMID: 21536172BACKGROUND

  • Beebe-Dimmer JL, Pfeifer JR, Engle JS, Schottenfeld D. The epidemiology of chronic venous insufficiency and varicose veins. Ann Epidemiol. 2005 Mar;15(3):175-84. doi: 10.1016/j.annepidem.2004.05.015.

    PMID: 15723761BACKGROUND

  • van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. Endovenous therapies of lower extremity varicosities: a meta-analysis. J Vasc Surg. 2009 Jan;49(1):230-9. doi: 10.1016/j.jvs.2008.06.030. Epub 2008 Aug 9.

    PMID: 18692348BACKGROUND

  • Geza M, Gloviczki P. Venous Embryology and Anatomy. In: Bergan JJ, editor. The Vein Book: Elsivier Academic Press; 2007.

    BACKGROUND

  • van Eekeren RR, Boersma D, de Vries JP, Zeebregts CJ, Reijnen MM. Update of endovenous treatment modalities for insufficient saphenous veins--a review of literature. Semin Vasc Surg. 2014 Jun;27(2):118-36. doi: 10.1053/j.semvascsurg.2015.02.002. Epub 2015 Feb 18.

    PMID: 25868763BACKGROUND

  • Guex JJ. Endovenous chemical (and physical) treatments for varices: what's new? Phlebology. 2014 May;29(1 suppl):45-48. doi: 10.1177/0268355514526331. Epub 2014 May 19.

    PMID: 24843085BACKGROUND

  • Davies HO, Popplewell M, Darvall K, Bate G, Bradbury AW. A review of randomised controlled trials comparing ultrasound-guided foam sclerotherapy with endothermal ablation for the treatment of great saphenous varicose veins. Phlebology. 2016 May;31(4):234-40. doi: 10.1177/0268355515595194. Epub 2015 Jul 9.

    PMID: 26163507BACKGROUND

MeSH Terms

Conditions

Venous InsufficiencyVaricose VeinsVascular Diseases

Interventions

Surveys and QuestionnairesRestraint, Physical

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthBehavior ControlTherapeuticsImmobilization

Study Officials

  • Tang Tjun Yip

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2020

First Posted

August 24, 2020

Study Start

May 9, 2020

Primary Completion

June 30, 2021

Study Completion

December 1, 2021

Last Updated

September 27, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)