Endoluminale Obliteration Der Stammvene Mit Dem 1470nm La... | NCT01972633

Studies
Endoluminale Obliteration Der Stammvene Mit Dem 1470nm Laser Versus VNUS Closure Fast

NCT01972633

Sponsor

Ludwig Boltzmann Institute for Operative Laparoscopy

Status

Unknown status

Last Update Posted

Oct 30, 2013Estimated

Enrollment

140Estimated

Phase

Phase 1Phase 2

Conditions

Venous Insufficiency

Interventions

Laser
Radiofrequency

Countries

Austria

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

Oct 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Mar 2014Estimated

Completion Date

Apr 2014Estimated

First Submitted Date

Dec 4, 2012

First Submission Date that Met QC Criteria

Oct 24, 2013

First Posted Date

Oct 30, 2013Estimated

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

Oct 24, 2013

Last Update Posted Date

Oct 30, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

There is a difference concerning obliteration rate and postoperative pain after treatment of the saphenous vein with 1470nm laser or VNUS Closure Fast (=radiofrequency method) .

Detailed Description

The endovenous treatment of the insufficient saphenous vein (large saphenous vein and small saphenous vein) is a standard procedure for years. There are different methods that cause an obliteration of the vein using heat. The adventage of these methods are low rates of minor and major complications compared to classic open surgery. There are also advantages concerning cosmetic and recurrence of varicous veins. Actually there are two different methods for the endovenous obliteration of the saphenous vein - lasers with wavelength of 1470nm or 1320nm and the radiofrequency method. The objective of this study is to compare these two different methods concerning postoperative pain, obliteration rate and the rate of pleased patients in 140 patients. All patients get an venous ultrasound investigation to determine the stadium of venous insufficiency. There are consecutive ultrasound investigations 10 days, 3 months and 12 months after surgical treatment.

In this study there are no additional risk factors for the included study patients except the risk of surgery.

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

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1470nm Laser	Active Comparator	Patient with varicose vein treated with 1470nm Laser (Biolitec)	Procedure: Laser Procedure: Radiofrequency
VNUS Closure Fast	Active Comparator	Patient with varicose vein treated with VNUS Closure Fast (Radiofrequency System)	Procedure: Laser Procedure: Radiofrequency

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laser	Procedure	Endovenous Laser (1470nm) ablation of great or small saphenous vein	1470nm Laser VNUS Closure Fast

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain	Pain (visual analogue scale) on the day of treatment	day 0

Secondary Outcomes

Measure	Description	Time Frame
Obliteration of the treated vein (GSV or SSV)	An ultrasound investigation of he treated vein is done to find out if the treated vein is fully obliterated or not. If it is not fully obliterated we want to find out if there is any pathological reflux in the vein.	day 10, month 3, month 12
Patient´s satisfaction after the intervention

Other Outcomes

Measure	Description	Time Frame
paresthesia of the lower leg after intervention	patients are asked if there is any paresthesia of the lower leg - "yes" or "no"	day 10, month 3, month 12

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

varicosis of great saphenous vein Hach-classification II-III (CEAP-classification: C3-4EPAS2-3PR and/or varicosis of small saphenous vein der Hach-classification I-III CEAP-classification: C3-4EPAS4PR)
maximum diameter of the great saphenous vein of 15mm maximum diameter of the small saphenous vein of 12mm

Exclusion Criteria:

surgical treatment of the saphenous vein in the past
sclerotherapy of the saphenous vein in the past
phlebitis or thrombosis of the saphenous vein
surgical treatment of an venous ulcer in the past
postthrombotic syndrome
erysipelas of the leg in the past
chronic treatment with pain-killers or chronic alcoholism
pregnancy
drug allergy against painkillers that are used in this study
spinal anesthesia not possible
compression bandage not possible
patients with polyneuropathy
patients with chronic pain
persons that do have a connection or persons that are working for one of the jused companies (Laser or VNUS Closure Fast)
participation on an other clinical trial that can interfere with this clinical trial
missing written informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Markus Schreiner	Contact	0043 732 7806 73295		office@chirurgie-schreiner.at
Andreas Shamiyeh	Contact	0043 732 7806 2133		andreas.shamiyeh@akh.linz.at

Overall Officials

Name	Affiliation	Role
Markus Schreiner	2.Chirurgische Abteilung AKh Linz GesmbH	Principal Investigator
Andreas Shamiyeh	2. Chirurgische Abteilung AKh Linz GesmbH	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
2.Chirurgische Abteilung AKh Linz GesmbH	Recruiting	Linz	Upper Austria	4020	Austria

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D055096	Optical Devices
D004864	Equipment and Supplies
D055618	Radiation Equipment and Supplies