MedDataX Logo

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

NCT ID: NCT07199439

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-23

Study Completion Date

2024-10-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Neurosurgery

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

bleeding

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

MDCECRO LLC

NETWORK

Sponsor Role collaborator

Medprin Regenerative Medical Technologies Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kaspars Auslands, Dr.

Role: PRINCIPAL_INVESTIGATOR

Riga's East Clinical University Hospital Riga, Latvia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Riga's East Clinical University Hospital Riga, Latvia

Riga, , Latvia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Latvia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

270323 - 4E

Identifier Type: OTHER

Identifier Source: secondary_id

MP-RD05-092

Identifier Type: -

Identifier Source: org_study_id