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

Ludwig Boltzmann Institute for Operative Laparoscopy

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Venous Insufficiency

Treatments: Procedure: Radiofrequency; Procedure: Laser

Study type: Interventional

Funder types: Other

Identifiers

NCT01972633

Boltzmann-001

Details and patient eligibility

About

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) .

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

1470nm Laser

Active Comparator group

Description:

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

Treatment:

Procedure: Laser

Procedure: Radiofrequency

VNUS Closure Fast

Active Comparator group

Description:

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

Treatment:

Procedure: Laser

Procedure: Radiofrequency