Status:
UNKNOWN
ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery - Liver Bleeding is Encountered
Lead Sponsor:
Biomedica Management Corporation
Collaborating Sponsors:
Washington University School of Medicine
Conditions:
Bleeding
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Phase 1 Single-Arm Study Evaluating ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery in Which Liver Bleeding is Encountered.
Detailed Description
In any open surgery bleeding usually occurs. Surgeons try to stop the bleeding by using his/her usual surgical practice. These include, but are not limited to: suturing (stitches), ligation (tying up)...
Eligibility Criteria
Inclusion
- Subject is expected to survive 6 months from the date of screening, If female and of child-bearing potential, subject has a negative serum pregnancy test prior to surgery and agrees to not breast feed her child (if applicable) for duration of study treatment and completion of study follow-up visits, If subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits
Exclusion
- pregnant females
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02264730
Start Date
July 1 2014
End Date
January 1 2015
Last Update
October 15 2014
Active Locations (1)
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1
Washington University School of Medicine Barnes Jewish Hospital Clinical Laboratory
St Louis, Missouri, United States, 63130