UnknownPhase 1/2

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

Austria140 participantsStarted 2010-06

Plain-language 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) .

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain

Timeframe: day 0

Trial details

NCT IDNCT01972633

SponsorLudwig Boltzmann Institute for Operative Laparoscopy

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-03

Contact for this trial

Markus Schreiner

0043 732 7806 73295 office@chirurgie-schreiner.at

View on ClinicalTrials.gov More Venous Insufficiency trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.