Gastrointestinal Hemorrhage Clinical Trial
Official title:
A Multi-centre Proof of Concept Study to Assess Efficacy and Safety of a New Liquid Endoscopic Hemostatic Agent (Seraseal / Fastact ®) in Patients With Active Gastrointestinal Bleeding
Verified date | January 2015 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Agency for Health and Food Safety |
Study type | Interventional |
Patients with active gastrointestinal bleeding can be included. 5ml of SerasealTM/Fastact (Wortham Laboratories, Chattanooga, USA), a CE-certified medical product for in human intraoperative use as hemostatic agent, is topically applied via catheters to the bleeding site. In group A, Seraseal is applied as initial method for hemostasis. In group B, Seraseal is applied after an initial failure of the institutional standard method. Homeostatic success is determined by 5 min without bleeding at gastrointestinal site. after application of Seraseal.
Status | Completed |
Enrollment | 37 |
Est. completion date | January 2015 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - active gastrointestinal hemorrhage Exclusion Criteria: - no sign of active bleeding at endoscopy |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | KH der Elisabethinen Linz | Linz | Oberoesterreich |
Austria | Division of Gastroenterology, Medical University of Vienna | Vienna | |
Austria | Rudolfstiftung | Vienna | |
Germany | Hannover Medical School | Hannover |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hemostasis | Success (=Hemostasis) for 5 minutes after Seraseal application | 5min | No |
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