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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07199439

Acronym

PMCFStypcel

Enrollment

108

Registered

2025-09-30

Start date

2023-04-23

Completion date

2024-10-15

Last updated

2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurosurgery

Keywords

bleeding

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 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Time to Hemostasis within 5 mins	during surgery (typically within 5 minutes）	The primary outcome is the time taken to achieve complete hemostasis at the surgical site after applying the StypCel™ Absorbable Hemostat during neurosurgery.
Time to Hemostasis	During surgery	Time to Hemostasis within 5 minutes

Countries

Latvia

Outcome results