NCT02080013

Brief Summary

our aim is to compare early outcomes following EVL 1320 nm and segmental RF in a randomized study.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2011

Typical duration for not_applicable

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

December 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
Last Updated

April 3, 2014

Status Verified

March 1, 2014

Enrollment Period

1.9 years

First QC Date

March 4, 2014

Last Update Submit

April 2, 2014

Conditions

Varicose Veins

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    30 days

Study Arms (2)

ClosureFast group

SHAM COMPARATOR

Radiofrequency Ablation for the Treatment of Great Saphenous Vein Reflux

Other: radiofrequency

group 1

SHAM COMPARATOR

EVL group Endovenous Laser Ablation for the Treatment of Great Saphenous Vein Reflux

Other: radiofrequency

Interventions

radiofrequencyOTHER

ClosureFAST

Also known as: ClosureFAST
ClosureFast groupgroup 1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients between the ages of 18 and 60 years with incompetent GSVs documented on duplex ultrasound (US; B-mode and color Doppler imaging) were eligible

You may not qualify if:

  • Current deep vein thrombosis (DVT)
  • Thrombus in the vein of interest
  • Previous GSV treatment
  • Pregnancy
  • Known malignancy
  • Significant arterial disease (ankle : brachial pressure index below 0•8)
  • Use of anticoagulant medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Hossam M. Saleh, PhD

    Vascular Surgery Department, Ain Shams University

    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
PRINCIPAL INVESTIGATOR
PI Title
A. Prof vascular surgery

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 6, 2014

Study Start

December 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

April 3, 2014

Record last verified: 2014-03