Status:
COMPLETED
Post-market Clinical Follow-up Plan of StypCel™ Absorbable Hemostat
Lead Sponsor:
Medprin Regenerative Medical Technologies Co., Ltd.
Collaborating Sponsors:
MDCECRO LLC
Conditions:
Neurosurgery
Eligibility:
All Genders
18-75 years
Brief Summary
This study is a post-market clinical follow-up (PMCF) plan for the StypCel™ Absorbable Hemostat, a medical device used to control bleeding during neurosurgery. The study include 108 patients . The aim...
Detailed Description
The StypCel™ Absorbable Hemostat is designed to control bleeding during neurosurgical procedures. This PMCF study is an observational, multicenter study included 108 patients .Primary goal is to evalu...
Eligibility Criteria
Inclusion
- Patients between 18-75 years of age
- Patients requiring a hemostat device during neurosurgery.
- Patients and/or guardians agree to take part in the PMCF study and sign the Informed Consent Form.
Exclusion
- Patients with bone defects, because it may interfere with callus formation and a possibility of cyst formation.
- StypCel™ should not be used in the control of hemorrhage from large arteries. StypCel™ should not be used as an anti-adhesion product.
- StypCel™ should not be used on the surface of non-hemorrhagic serous effusion, because in addition to the whole blood, the fluid does not react with the absorbable hemostat with satisfied hemostatic effect.
- StypCel™ is to be avoided in surgical cases requiring stuffing and packing (as is sometimes medically necessary). It may only be used in such a situation if the surgeon completely removes the device after hemostasis is achieved.
Key Trial Info
Start Date :
April 23 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 15 2024
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT07199439
Start Date
April 23 2023
End Date
October 15 2024
Last Update
September 30 2025
Active Locations (1)
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1
Riga's East Clinical University Hospital Riga, Latvia
Riga, Latvia