NCT07199439

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

Multicentre, Prospective, Post Market Observational Registry Study to Observe the Performance and Safety of the StypCel™ Device to Achieve Hemostasis During Neurosurgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 108 (actual)
• Sponsor: Medprin Regenerative Medical Technologies Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 of the study is to furtherly assess the safety and performance of the device under the real-word setting

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 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. 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.

Conditions

• Neurosurgery

Timeline

• Start date: 2023-04-23
• Primary completion: 2023-04-25
• Completion: 2024-10-15
• First posted: 2025-09-30
• Last updated: 2025-09-30

Locations

1 site across 1 country: Latvia