NCT02441881

Brief Summary

A double blind randomised controlled trial of radiofrequency thermal ablation treatments of great saphenous varicose veins: Venefit (Closurefast), vs. Radiofrequency induced Thermal Therapy vs. Endovenous Radiofrequency. Assessments by visual pain scores, duplex ablation and quality of life questionaires

Trial Health

87
On Track

Trial Health Score

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

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 5, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

2.6 years

First QC Date

April 27, 2015

Last Update Submit

October 28, 2017

Conditions

Varicose Veins

Keywords

Radiofrequency ablationvaricose veinsendothermal ablationRFITTVenefit

Outcome Measures

Primary Outcomes (1)

  • Percentage of participants with 100% ablation of the previously treated vein segment

    Duplex confirmed absence of recanalisation of the ablated

    6 months

Secondary Outcomes (2)

  • Pain score on the visual scale

    7 days

  • Quality of life measured by SF36, Euroqual 5D and Aberdeen varicose veins questionnaire

    12 months

Study Arms (3)

Venefit

ACTIVE COMPARATOR

Endovenous radiofrequency ablation device for truncal great saphenous vein ablation

Device: Venefit

Radiofrequency Induced Thermal Therapy

ACTIVE COMPARATOR

Endovenous radiofrequency ablation device for truncal great saphenous vein ablation

Device: Radiofrequency Induced Thermal Therapy

Endovenous Radiofrequency

ACTIVE COMPARATOR

Endovenous radiofrequency ablation device for truncal great saphenous vein ablation

Device: Endovenous Radiofrequency

Interventions

VenefitDEVICE

Endovenous radiofrequency device

Also known as: Closurefast
Venefit
Radiofrequency Induced Thermal TherapyDEVICE

Endovenous radiofrequency device

Also known as: RFITT
Radiofrequency Induced Thermal Therapy
Endovenous RadiofrequencyDEVICE

Endovenous radiofrequency device

Also known as: EVRF
Endovenous Radiofrequency

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic primary varicose veins of the great saphenous vein (GSV)
  • Able to give informed consent to participate in the study after reading the patient information sheet
  • Patients aged \>18 years and \< 80 years
  • Ankle Brachial Pressure Index (ABPI) \>/= 0.8

You may not qualify if:

  • Unable to give informed consent
  • Tortuous GSV not amenable to endovenous treatment
  • Recurrent varicose veins (previous surgery)
  • Presence of deep venous occlusive disease or other conditions precluding superficial venous intervention (at the discretion of the research team)
  • Patients who are needle phobic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Worcestershire Royal Hospital

Worcester, Worcestershire, WR5 1DD, United Kingdom

Location

Related Publications (2)

  • Nyamekye IK, Dattani N, Hayes W, Harding D, Holloway S, Newman J. A Randomised Controlled Trial Comparing Three Different Radiofrequency Technologies: Short-Term Results of the 3-RF Trial. Eur J Vasc Endovasc Surg. 2019 Sep;58(3):401-408. doi: 10.1016/j.ejvs.2019.01.033. Epub 2019 Jul 24.

    PMID: 31351832DERIVED

  • Gough MJ. Radiofrequency Venous Ablation: Not Simple and Not Always Effective! Eur J Vasc Endovasc Surg. 2019 Sep;58(3):409. doi: 10.1016/j.ejvs.2019.04.010. Epub 2019 May 21. No abstract available.

    PMID: 31126836DERIVED

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Isaac K Nyamekye, MD, FRCS

    Worcestershire Acute Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2015

First Posted

May 12, 2015

Study Start

September 5, 2014

Primary Completion

March 28, 2017

Study Completion

September 30, 2017

Last Updated

October 31, 2017

Record last verified: 2017-10

Locations

GB(1)