Post-market Clinical Follow-up Plan of StypCel™ Absorbable Hemostat
- Conditions
- Neurosurgical Procedures
- Registration Number
- NCT06578130
- Lead Sponsor
- MDCECRO LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 108
Inclusion Criteria:<br><br> - Patients between 18-75 years of age<br><br> - Patients requiring a hemostat device during neurosurgery.<br><br> - Patients and/or guardians agree to take part in the PMCF study and sign the Informed<br> Consent Form.<br><br>Exclusion Criteria:<br><br> - Patients with bone defects, because it may interfere with callus formation and a<br> possibility of cyst formation.<br><br> - StypCel™ should not be used in the control of hemorrhage from large arteries.<br><br> - StypCel™ should not be used as an anti-adhesion product.<br><br> - StypCel™ should not be used on the surface of non-hemorrhagic serous effusion,<br> because in addition to the whole blood, the fluid does not react with the absorbable<br> hemostat with satisfied hemostatic effect.<br><br> - StypCel™ is to be avoided in surgical cases requiring stuffing and packing (as is<br> sometimes medically necessary). It may only be used in such a situation if the<br> surgeon completely removes the device after hemostasis is achieved.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to Hemostasis
- Secondary Outcome Measures
Name Time Method Rate of Intracranial Infections;Rate of Serious Adverse Events