Post-market Clinical Follow-up Plan of StypCel™ Absorbable Hemostat

MDCECRO LLC

Status: Active, not recruiting

Conditions: Neurosurgical Procedures

Treatments: Device: StypCel™ Absorbable Hemostat

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT06578130

MP-RD05-92

Details and patient eligibility

About

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 will monitor the device's safety and effectiveness in real-world conditions across multiple sites. It will include 108 patients who require the device during neurosurgery and will observe the time it takes to achieve hemostasis and track any complications, including infections and other serious adverse events. The study aims to ensure the continued safety and effectiveness of the device after it has been introduced to the market.

Full description

The StypCel™ Absorbable Hemostat is designed to control bleeding during neurosurgical procedures. This PMCF study is an observational, multicenter investigation that will include 108 patients across up to 8 medical sites. The study's primary goal is to evaluate the device's ability to achieve hemostasis within 5 minutes during surgery. Secondary objectives include monitoring the rate of intracranial infections and other serious adverse events over 6 months. The study will help to confirm the safety and performance of the StypCel™ device in everyday clinical use and ensure it meets the required standards for patient safety. Data from the study will be collected at two-time points: 10 days and 180 days after the surgery, with follow-up assessments to monitor any delayed complications.

These summaries are written in plain language, ensuring they are accessible to non-specialists while still providing essential information about the study's objectives, methodology, and expected outcomes.

Enrollment: 108 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

108 participants in 1 patient group

StypCel™ Neurosurgery Patients

Description:

This cohort includes patients undergoing neurosurgery where the StypCel™ Absorbable Hemostat is used to achieve hemostasis. The study will observe and document the effectiveness of the device in controlling bleeding during the surgery and track any subsequent complications, including infections and other adverse events, over a 6-month follow-up period.

Treatment:

Device: StypCel™ Absorbable Hemostat