ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery - Liver Bleeding is Encountered
ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery - Liver Bleeding is Encountered
Phase 1 Single-Arm Study Evaluating ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery
 in Which Liver Bleeding is Encountered.
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) or cautery (to burn in order to stop or prevent bleeding). It is often
 necessary for surgeons to use an additional treatment to stop the bleeding. This may include
 the use of a hemostatic product (used to stop bleeding).

 This Phase I study consists of a single arm evaluating the safety of ClotFoam as an adjunct
 to hemostasis. ClotFoam® is an investigational product-a gelatin-based hydrogel carrying a
 fibrin monomer-that has been designed for supportive treatment in general surgery for the
 improvement of hemostasis, where standard techniques are insufficient.

 The evaluation will be conducted in 24 patients who are scheduled to undergo elective open
 surgery in which liver bleeding is encountered requiring control of mild-to- moderate
 bleeding where standard surgical techniques are expected to be ineffective and/or
 impractical. All subjects who meet eligibility criteria and who provide informed consent to
 participate will be assigned to ClotFoam topical treatment. Subjects who will be screened for
 eligibility to participate in this study will be those who are scheduled to with undergo an
 elective (non-emergency) hepatic wedge resection or anatomic resection (of 1 to 5 contiguous
 hepatic segments or a surgical procedure in which liver bleeding is encountered such as
 removal of the gall bladder (open), bile duct excision wherein an appropriate target bleeding
 site is identified.

 Subjects undergoing living-related liver donation are also eligible. Participants will have
 post-operative follow ups at day 1,2,5, and 10 post-procedure, 2 weeks post procedure, and 12
 weeks post-procedure. The follow up visits will consist of safety evaluations (physical exam,
 adverse event assessment, laboratory evaluations).
Inclusion Criteria:

 -  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 Criteria:

 -  pregnant females