Comparison of the Hemostatic Patch to Fibrin Sealant (TachoSil®) in Subjects Undergoing Hepatic Surgery
Launched by MEDTRONIC - MITG · Mar 28, 2011
Trial Information
Current as of April 27, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Major Inclusion Criteria:
- • Scheduled for non-emergent, hepatic surgery
- • Presence of an appropriate target bleeding site (TBS) as defined by the protocol
- Major Exclusion Criteria:
- • Subject will be undergoing a laparoscopic hepatic procedure where the Hemostatic Patch will be delivered and applied through a trocar
- • In subjects with documented history of cirrhosis, subject has uncorrected platelet count \<60,000 per mm³ as determined by laboratory tests performed immediately prior to surgery
- • Subject has severe coagulopathy defined as INR \> 2.0
- • Subject has Total Bilirubin \>2.5mg/dL
- • Subject has an active local infection at the Target Bleeding Site
- • Study procedure involves a liver transplant recipient
About Medtronic Mitg
Medtronic - Minimally Invasive Therapies Group (MITG) is a leading global sponsor focused on advancing minimally invasive surgical techniques and technologies to improve patient outcomes and optimize healthcare delivery. Committed to innovation and excellence, MITG develops a range of products and solutions that enhance surgical precision and efficiency, catering to a diverse array of medical conditions. Through rigorous clinical trials and research initiatives, Medtronic MITG aims to drive evidence-based practices in healthcare, ensuring that patients benefit from the latest advancements in minimally invasive procedures.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Heidelberg, , Germany
Gent, , Belgium
Innsbruck, , Austria
Leuven, , Belgium
München, , Germany
Hannover, , Germany
Patients applied
Trial Officials
Amy Pollack, MD
Study Director
Medtronic - MITG
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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