HEMOBLAST Pilot Clinical Investigation
Condition: Hemostasis
Intervention: HEMOBLAST Bellows
Intervention description: HEMOBLAST™ Bellows is intended for use in surgical procedures as an adjunct to hemostasis when control of bleeding by conventional procedures is ineffective or impractical.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      The primary objective of this pilot clinical investigation is to assess the reliability of
      the Surface Bleeding Severity Scale (SBSS) in a clinical setting. Secondary objectives of
      this clinical investigation are to collect initial data on the safety and efficacy of
      HEMOBLAST™ Bellows in abdominal and orthopedic lower extremity surgeries.
    

Eligibility criteria:

        Inclusion Criteria:

          -  • Subject is undergoing an elective open abdominal or orthopedic lower extremity
             surgery;

               -  Subject or an authorized legal representative is willing and able to give prior
                  written informed consent for investigation participation;

               -  Subjects on antiplatelets, including aspirin, will discontinue medication at
                  least 10 days prior to surgery; and

               -  Subject is 21 years of age or older.

               -  Subject does not have an active or suspected infection at the surgical site;

               -  Subject in whom the Investigator is able to identify a target bleeding site (TBS)
                  for which any applicable conventional means for achieving hemostasis are
                  ineffective or impractical; and

               -  Subject has a TBS with an SBSS score of 1, 2, or 3.

        Exclusion Criteria:

          -  • Subject is undergoing a laparoscopic, thoracoscopic, or robotic surgical procedure;

               -  Subject is undergoing a spinal surgical procedure;

               -  Subject is undergoing a neurologic surgical procedure;

               -  Subject is undergoing an emergency surgical procedure;

               -  Subject is pregnant, planning on becoming pregnant during the follow-up period,
                  or actively breast-feeding;

               -  Subject has a clinically significant coagulation disorder or disease, defined as
                  a platelet count < 100,000 per microliter and/or International Normalized Ratio >
                  1.5 within 4 weeks of surgery;

               -  Subject had chronic corticosteroid use within 2 weeks prior to surgery;

               -  Subject receiving intravenous heparin or oral Coumadin within 24 hours of
                  surgery;

               -  Subject has an active or suspected infection at the surgical site;

               -  Subject has had or has planned any organ transplantation;

               -  Subject has a known sensitivity or allergy to bovine and/or porcine substance(s)
                  or any other component(s) of the hemostatic agent;

               -  Subject has ASA classification of > 4;

               -  Subject has a life expectancy of less than 3 months;

               -  Subject has a known psychiatric disorder, which in the opinion of the Principal
                  Investigator, would preclude the subject from completing this clinical study;

               -  Subject has a documented severe congenital or acquired immunodeficiency;

               -  Subject has religious or other objections to porcine or bovine components;

               -  Subject in whom the investigational device will be used at the site of a cemented
                  or uncemented porous coated joint implant;

               -  Subject is currently participating or has participated in another clinical trial
                  within the past 30 days and is receiving/has received an investigational drug,
                  device, or biologic agent; and

               -  Subject is not appropriate for inclusion in the clinical trial, per the medical
                  opinion of the Principal Investigator.