Endoluminale Obliteration Der Stammvene Mit Dem 1470nm Laser Versus VNUS Closure Fast
Endovenous Treatment of the Saphenous Vein With Biolitec 1470nm Laser Versus Vnus Closure Fast
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
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-
Oberösterreich
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Linz、Oberösterreich、オーストリア、4020
- 募集
- 2.Chirurgische Abteilung AKh Linz GesmbH
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コンタクト：
- Katharina Bröderbauer
- 電話番号：0043 732 7806 2133
- メール：chirurgie2@akh.linz.at
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主任研究者：
- Markus MS Schreiner
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：1470nm Laser
Patient with varicose vein treated with 1470nm Laser (Biolitec)
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Endovenous Laser (1470nm) ablation of great or small saphenous vein
Endovenous Radiofrequency (VNUS Closure Fast) of great or small saphenous vein
|
|
アクティブコンパレータ：VNUS Closure Fast
Patient with varicose vein treated with VNUS Closure Fast (Radiofrequency System)
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Endovenous Laser (1470nm) ablation of great or small saphenous vein
Endovenous Radiofrequency (VNUS Closure Fast) of great or small saphenous vein
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain
時間枠：day 0
|
Pain (visual analogue scale) on the day of treatment
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day 0
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Obliteration of the treated vein (GSV or SSV)
時間枠：day 10, month 3, month 12
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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.
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day 10, month 3, month 12
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Patient´s satisfaction after the intervention
時間枠：day 10, month 3, month 12
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The patient is asked about his/her satisfaction after intervention.
This is measured on a numeric scale from 1 to 5 (like schoolmarks in austria or germany).
1=very good, 2=good, 3=average, 4=not so good, 5=bad)
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day 10, month 3, month 12
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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paresthesia of the lower leg after intervention
時間枠：day 10, month 3, month 12
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patients are asked if there is any paresthesia of the lower leg - "yes" or "no"
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day 10, month 3, month 12
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協力者と研究者
捜査官
- 主任研究者：Markus Schreiner、2.Chirurgische Abteilung AKh Linz GesmbH
- スタディチェア：Andreas Shamiyeh、2. Chirurgische Abteilung AKh Linz GesmbH
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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