- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02164201
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.
Studieöversikt
Status
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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)
Beskrivning
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).
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Achievement of haemostasis
Tidsram: 3 minutes after application
|
3 minutes after application
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Time to haemostasis
Tidsram: measured through to 10 minutes
|
measured through to 10 minutes
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Bernhard Voss, PD Dr Med, Deutsches Herzzentrum Muenchen
- Huvudutredare: Ottavio Alfieri, Professor, San Raffale Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BFM1301.000-M
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