Post Market Surveillance Study Evaluating BioFoam Surgical Matrix in Cardiovascular Surgery
Post Market Surveillance Study Evaluating the Operative Management of Anastomotic Bleeding by Means of an Adjunctive Application of BioFoam Surgical Matrix in Cardiovascular Surgery
This is a prospective, multicenter, single-arm study designed to collect clinical data to support the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery.
The overall objective of this clinical study is to collect clinical data supporting the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery. This study is intended as a post-market surveillance (follow-up) study.
調査の概要
状態
研究の種類
入学 (実際)
連絡先と場所
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
サンプリング方法
調査対象母集団
Patients undergoing cardiac or cardiovascular procedures, including, but not limited to:
Thoracic Aortic Aneurysm Aortic Valve Replacement Type A Aortic Dissection (where BioFoam is limited to the anastomotic site)
説明
Inclusion Criteria:
- Subject is undergoing an elective cardiac or cardiovascular procedure;
- Subject is willing and able to give prior written informed consent for investigation participation; and
- Subject is > 18 years of age.
Intraoperative inclusion criteria include:
• Subject that requires the use of an adjunctive surgical hemostatic agent to the repair site to control generalized oozing following standard repair procedures (such as sutures and staples).
Exclusion Criteria:
• Subject with known hypersensitivity to albumin, bovine products, or glutaraldehyde;
- Subject with active infection (either systemic or in the repair region);
- Subject whose pathology or underlying disease state makes them an unacceptable candidate for a clinical investigation in the opinion of the Investigator;
- Subject diagnosed with a coagulation disorder;
- Subject with abnormal calcium metabolism (e.g., chronic renal failure, hyperparathyroidism);
- Subject whose life expectancy is less than that required for the prescribed follow-up duration;
- Subject who is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding; or
- Subject who is immunocompromised.
Intraoperative exclusion criteria include:
• Any major intraoperative bleeding incidences (i.e., American College of Surgeons Advanced Trauma Life Support Class II, III, or IV Hemorrhage).
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
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 |
時間枠 |
|---|---|
|
Achievement of haemostasis
時間枠：3 minutes after application
|
3 minutes after application
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Time to haemostasis
時間枠：measured through to 10 minutes
|
measured through to 10 minutes
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Bernhard Voss, PD Dr Med、Deutsches Herzzentrum Muenchen
- 主任研究者：Ottavio Alfieri, Professor、San Raffale Hospital
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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。