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

NCT ID: NCT01972633

Last Updated: 2013-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2014-04-30

Brief Summary

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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

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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.

Conditions

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Venous Insufficiency

Keywords

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endovenous treatment Laser, Vnus Closure Fast Varicosis great saphenous vein small saphenous vein Venous Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1470nm Laser

Patient with varicose vein treated with 1470nm Laser (Biolitec)

Group Type ACTIVE_COMPARATOR

Laser

Intervention Type PROCEDURE

Endovenous Laser (1470nm) ablation of great or small saphenous vein

Radiofrequency

Intervention Type PROCEDURE

Endovenous Radiofrequency (VNUS Closure Fast) of great or small saphenous vein

VNUS Closure Fast

Patient with varicose vein treated with VNUS Closure Fast (Radiofrequency System)

Group Type ACTIVE_COMPARATOR

Laser

Intervention Type PROCEDURE

Endovenous Laser (1470nm) ablation of great or small saphenous vein

Radiofrequency

Intervention Type PROCEDURE

Endovenous Radiofrequency (VNUS Closure Fast) of great or small saphenous vein

Interventions

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Laser

Endovenous Laser (1470nm) ablation of great or small saphenous vein

Intervention Type PROCEDURE

Radiofrequency

Endovenous Radiofrequency (VNUS Closure Fast) of great or small saphenous vein

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig Boltzmann Institute for Operative Laparoscopy

OTHER

Sponsor Role lead

Responsible Party

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Dr. Markus Schreiner

Oberarzt

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Markus Schreiner

Role: PRINCIPAL_INVESTIGATOR

2.Chirurgische Abteilung AKh Linz GesmbH

Andreas Shamiyeh

Role: STUDY_CHAIR

2. Chirurgische Abteilung AKh Linz GesmbH

Locations

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2.Chirurgische Abteilung AKh Linz GesmbH

Linz, Upper Austria, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Markus Schreiner

Role: CONTACT

Phone: 0043 732 7806 73295

Email: [email protected]

Andreas Shamiyeh

Role: CONTACT

Phone: 0043 732 7806 2133

Email: [email protected]

Facility Contacts

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Katharina Bröderbauer

Role: primary

Other Identifiers

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Boltzmann-001

Identifier Type: -

Identifier Source: org_study_id