NCT03685838

Brief Summary

This study will be looking at the effect of compression therapy in patients having Mechano-Chemical Ablation (MOCA) therapy for truncal incompetence of their varicose veins using the ClariVein® device. Patients will be randomised to either the compression group (group A) or the no compression group (group B). The pain scores, compliance, quality of life scores, occlusion rate at 6 months as well as the cost effectiveness of each intervention will be assessed.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

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

First Submitted

Initial submission to the registry

September 21, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

February 13, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

2.6 years

First QC Date

September 21, 2018

Last Update Submit

October 29, 2020

Conditions

Varicose VeinsChronic Venous Insufficiency

Keywords

mechano-chemical ablationcompression stockings

Outcome Measures

Primary Outcomes (1)

  • Pain Score post-procedure

    Participants will record their pain score using the Visual Analogue Score (VAS) for pain. The scale ranges from 0 (no pain) to 10 (worst pain imaginable).

    First 10 days post-procedure

Secondary Outcomes (10)

  • Quality of Life score using the EQ-5D questionnaire

    Baseline, 2 weeks post-op, 6 months post-op

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

    Baseline, 2 weeks post-op, 6 months post-op

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

    Baseline, 2 weeks post-op, 6 months post-op

  • Clinical Change using Venous Clinical Severity Score (VCSS)

    Baseline, 2 weeks post-op, 6 months post-op

  • Time taken to return to work and normal activities

    10 days post-op

  • +5 more secondary outcomes

Study Arms (2)

Compression

ACTIVE COMPARATOR

Patient will receive Class II above knee compression stockings, and will be asked to wear it for 1 week. This would involve wearing the stocking during daytime but patients will be allowed to take it off at night whilst in bed.

Other: Compression Stockings

No Compression

NO INTERVENTION

Patient will not receive any compression stockings.

Interventions

Compression StockingsOTHER

Class II above knee compression stockings

Compression

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\>=21 to \<=80
  • Able to walk unassisted and attend follow-up visits
  • Symptomatic Great Saphenous Vein (GSV) or Small Saphenous Vein (SSV) vein reflux \>0.5 seconds on colour Duplex ultrasound
  • Able to provide informed consent

You may not qualify if:

  • Previous or current deep vein thrombosis or pulmonary embolism
  • Patients with a hypercoaguable state
  • Previous thrombophlebitis in the truncal vein in question, which had recanalized and was now incompetent on duplex ultrasound
  • Recurrent varicose vein i.e. patients who have had treatment previously in the designated truncal vein with any modality
  • Patients who have had treatment in either leg for an incompetent saphenous truncal vein less than 3 months prior to treatment and enrolment into this study
  • Patients requiring adjuvant treatment of varicose veins
  • Arterial disease (ABPI \< 0.6 and the absence of a palpable pedal pulse)
  • Vein diameter \<3mm or \>12mm as measured in the standing position on duplex ultrasound
  • Varicose veins unsuitable for MOCA (e.g. very tortuous vein)
  • Pregnancy
  • Lycra, sclerosant or local anaesthetic allergy
  • Patients who have opted for an alternative method of treatment
  • Patients with fibromyalgia
  • Patients with Clinical, Etiologic, Anatomic and Pathophysiologic (CEAP) score of C6 (active ulcer), C1 and C2 (asymptomatic) disease
  • Patients with a life expectancy less than 12 months
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Galway University Hospital

Galway, Galway, Ireland

RECRUITING

Singapore General Hospital

Singapore, Singapore

RECRUITING

Related Publications (13)

  • Evans CJ, Fowkes FG, Ruckley CV, Lee AJ. Prevalence of varicose veins and chronic venous insufficiency in men and women in the general population: Edinburgh Vein Study. J Epidemiol Community Health. 1999 Mar;53(3):149-53. doi: 10.1136/jech.53.3.149.

    PMID: 10396491BACKGROUND

  • Sakurai H, Naito H. A cross-resistance of Pyricularia oryzae Cavara to kasugamycin and blasticidin S. J Antibiot (Tokyo). 1976 Dec;29(12):1341-2. doi: 10.7164/antibiotics.29.1341. No abstract available.

    PMID: 1051420BACKGROUND

  • Biemans AA, Kockaert M, Akkersdijk GP, van den Bos RR, de Maeseneer MG, Cuypers P, Stijnen T, Neumann MH, Nijsten T. Comparing endovenous laser ablation, foam sclerotherapy, and conventional surgery for great saphenous varicose veins. J Vasc Surg. 2013 Sep;58(3):727-34.e1. doi: 10.1016/j.jvs.2012.12.074. Epub 2013 Jun 13.

    PMID: 23769603BACKGROUND

  • MacKenzie RK, Paisley A, Allan PL, Lee AJ, Ruckley CV, Bradbury AW. The effect of long saphenous vein stripping on quality of life. J Vasc Surg. 2002 Jun;35(6):1197-203. doi: 10.1067/mva.2002.121985.

    PMID: 12042731BACKGROUND

  • 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

  • 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

  • Marsden G, Perry M, Kelley K, Davies AH; Guideline Development Group. Diagnosis and management of varicose veins in the legs: summary of NICE guidance. BMJ. 2013 Jul 24;347:f4279. doi: 10.1136/bmj.f4279. No abstract available.

    PMID: 23884969BACKGROUND

  • Edwards AG, Baynham S, Lees T, Mitchell DC. Management of varicose veins: a survey of current practice by members of the Vascular Society of Great Britain and Ireland. Ann R Coll Surg Engl. 2009 Jan;91(1):77-80. doi: 10.1308/003588409X358953. Epub 2008 Nov 4.

    PMID: 18990266BACKGROUND

  • Fonken LK, Weil ZM, Nelson RJ. Mice exposed to dim light at night exaggerate inflammatory responses to lipopolysaccharide. Brain Behav Immun. 2013 Nov;34:159-63. doi: 10.1016/j.bbi.2013.08.011. Epub 2013 Sep 6.

    PMID: 24012645BACKGROUND

  • Elderman JH, Krasznai AG, Voogd AC, Hulsewe KW, Sikkink CJ. Role of compression stockings after endovenous laser therapy for primary varicosis. J Vasc Surg Venous Lymphat Disord. 2014 Jul;2(3):289-96. doi: 10.1016/j.jvsv.2014.01.003. Epub 2014 Feb 14.

    PMID: 26993388BACKGROUND

  • Hamel-Desnos CM, Guias BJ, Desnos PR, Mesgard A. Foam sclerotherapy of the saphenous veins: randomised controlled trial with or without compression. Eur J Vasc Endovasc Surg. 2010 Apr;39(4):500-7. doi: 10.1016/j.ejvs.2009.11.027. Epub 2010 Jan 25.

    PMID: 20097585BACKGROUND

  • Whiteley MS, Dos Santos SJ, Fernandez-Hart TJ, Lee CT, Li JM. Media Damage Following Detergent Sclerotherapy Appears to be Secondary to the Induction of Inflammation and Apoptosis: An Immunohistochemical Study Elucidating Previous Histological Observations. Eur J Vasc Endovasc Surg. 2016 Mar;51(3):421-8. doi: 10.1016/j.ejvs.2015.11.011. Epub 2016 Jan 17.

    PMID: 26790396BACKGROUND

  • Joyce DP, Walsh SR, Yap CJQ, Chong TT, Tang TY. Compression therapy following ClariVein(R) ablation therapy: a randomised controlled trial of COMpression Therapy Following MechanO-Chemical Ablation (COMMOCA). Trials. 2019 Dec 5;20(1):678. doi: 10.1186/s13063-019-3787-4.

    PMID: 31806052DERIVED

MeSH Terms

Conditions

Varicose Veins

Interventions

Stockings, Compression

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Compression BandagesBandagesEquipment and Supplies

Study Officials

  • Tang Tjun Yip

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tang Tjun Yip

CONTACT

65767986tang.tjun.yip@singhealth.com.sg

Charyl Yap

CONTACT

charyl.yap.j.q@sgh.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2018

First Posted

September 26, 2018

Study Start

February 13, 2019

Primary Completion

October 1, 2021

Study Completion

October 1, 2022

Last Updated

October 30, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)SG(1)