Evaluation of Safety of HEMOBLAST Bellows in Spine Surgery

Launched by DILON TECHNOLOGIES INC. · Jan 29, 2021

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject is undergoing open, elective, spine surgery
• • Subject or an authorized legal representative is willing and able to give prior written informed consent for investigation participation
• • Subject is 22 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 hemostasis are ineffective or impractical
• • Subject has a TBS with a Surface Bleeding Severity Scale (SBSS) score of 1, 2, or 3
• Exclusion Criteria:
• • Subject is undergoing an emergency surgical procedure
• • Subject is undergoing a laparoscopic surgery
• • Subject is undergoing a cervical spine surgery
• • Subject is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding
• • Subject has a platelet count \< 100,000 per microliter or International Normalized Ratio \> 1.5 within 4 weeks of surgery
• • Subject receiving intravenous heparin within 12 hours before surgery or oral Coumadin within 2 days before surgery
• • Subject receiving antiplatelet medications within 5 days prior to surgery
• • Subject receiving aspirin within 7 days prior to surgery
• • Subject has an active or suspected infection at the surgical site
• • Subject has had or has planned to receive 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 a known sensitivity or allergy to Gadolinium
• • The subject has a contra-indication for MRI or gadolinium contrast agent according to clinical guidelines, local regulations or manufacturer's recommendations
• • Subject suffers from claustrophobia or fear of MRI, or has any contraindication to MRI (e.g., metal implants, spinal cord stimulator, etc. not suited to MRI)
• • Subject has American Society of Anesthesiologists classification of \> 4
• • Subject has a life expectancy of less than 3 months
• • Subject has a documented severe congenital or acquired immunodeficiency
• • Subject has religious or other objections to porcine, bovine, or human components
• • 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
• • Per investigator opinion subject is unable to fully cooperate with the study protocol.
• • The product will be placed in at the site where the dura is open
• • The product will be placed in the intradural or cranial space