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

NCT07199439 | Completed

• 2 other identifiers: MP-RD05-092270323 - 4E
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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

Conditions

Neurosurgery

Keywords

bleeding

Outcome Measures

Primary Outcomes (2)

• Time to Hemostasis within 5 mins

  The primary outcome is the time taken to achieve complete hemostasis at the surgical site after applying the StypCel™ Absorbable Hemostat during neurosurgery.

  during surgery (typically within 5 minutes）

• Time to Hemostasis

  Time to Hemostasis within 5 minutes

  During surgery

Study Arms (1)

StypCel™ Neurosurgery Patients

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes adult patients undergoing neurosurgical procedures where the StypCel™ Absorbable Hemostat is used to control intraoperative bleeding. The population is drawn from multiple hospitals specializing in neurosurgery

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medprin Regenerative Medical Technologies Co., Ltd.: lead
• MDCECRO LLC: collaborator

Study Sites (1)

Riga's East Clinical University Hospital Riga, Latvia

Riga, Latvia

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kaspars Auslands, Dr.

  Riga's East Clinical University Hospital Riga, Latvia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start: April 23, 2023
• Primary Completion: April 25, 2023
• Study Completion: October 15, 2024
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1)