Status:
COMPLETED
Hemopatch Performance Evaluation: A Prospective Observational Registry
Lead Sponsor:
Baxter Healthcare Corporation
Conditions:
Dura Mater Nick Cut or Tear
Hemostatis
Eligibility:
All Genders
Brief Summary
To assess the clinical performance and safety of HEMOPATCH Sealing Hemostat in a post-marketing setting in cardiovascular, thoracic, urologic, neurological, and other general surgical procedures.
Eligibility Criteria
Inclusion
- Male or female patients of any age
- Patients who had undergone open or minimal invasive surgical (MIS) procedures requiring the use of a patch to achieve dura repair, hemostasis, or control of leakage of air or other body fluid when pressure, ligature or other conventional procedures had been ineffective or impractical and where use of hemopatch was deemed appropriate by the surgeon according to its IFU in the following organ systems:
- Hepato-biliary (liver, pancreas, gallbladder)
- General surgery (in thyroid and other regions)
- Cardiovascular (heart and vessels)
- thoracic (lung and mediastinum)
- Urological (kidney, prostate, and bladder
- Neurological (dura mater, brain and spinal cord)
- Provision of written informed consent/assent, as applicable, up to 72 hours after the date of surgery
Exclusion
- Patients with known hypersensitivity to bovine proteins or brilliant blue
- Patients who had intraoperative pulsatile or severe bleeding at the target application site (TAS)
- Patients who had an active infection at the TAS
Key Trial Info
Start Date :
November 29 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 28 2019
Estimated Enrollment :
621 Patients enrolled
Trial Details
Trial ID
NCT03392662
Start Date
November 29 2017
End Date
January 28 2019
Last Update
November 16 2022
Active Locations (15)
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1
Innsbruck Universitaetsklinik
Innsbruck, Austria, 6020
2
Fakultní nemocnice u sv. Anny v Brně
Brno, Czechia, 65691
3
Krajská Nemocnice Liberec
Liberec, Czechia, 46063
4
Fakultní Nemocnice Ostrava
Ostrava, Czechia, 70852