Endovenous Radiofrequency Versus Laser Ablation for the T... | NCT02080013

Studies
Endovenous Radiofrequency Versus Laser Ablation for the Treatment of Great Saphenous Vein Reflux

NCT02080013

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Apr 3, 2014Estimated

Enrollment

5Actual

Phase

Not Applicable

Conditions

Varicose Veins

Interventions

radiofrequency

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Mar 4, 2014

First Submission Date that Met QC Criteria

Mar 5, 2014

First Posted Date

Mar 6, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2014

Last Update Posted Date

Apr 3, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Endovenous Radiofrequency versus Laser Ablation for the Treatment of Great Saphenous Vein Reflux

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
radiofrequency	Other	ClosureFAST	ClosureFast group group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability		30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Exclusion criteria consisted of:
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hossam M. Saleh, PhD	Vascular Surgery Department, Ain Shams University	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014648	Varicose Veins

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided