Post-market Clinical Follow-up Plan of StypCel™ Absorbabl... | NCT07199439

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

NCT07199439

Sponsor

Medprin Regenerative Medical Technologies Co., Ltd.

Status

Completed

Last Update Posted

Sep 30, 2025Actual

Enrollment

108Actual

Phase

Not provided

Conditions

Neurosurgery

Interventions

Not provided

Countries

Latvia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
270323 - 4E	Other Identifier	Latvian Ethics Committee for Clinical Research

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 23, 2023Actual

Primary Completion Date

Apr 25, 2023Actual

Completion Date

Oct 15, 2024Actual

First Submitted Date

Sep 22, 2025

First Submission Date that Met QC Criteria

Sep 22, 2025

First Posted Date

Sep 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2025

Last Update Posted Date

Sep 30, 2025Actual

Name	Class
MDCECRO LLC	NETWORK

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

108Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kaspars Auslands, Dr.	Riga's East Clinical University Hospital Riga, Latvia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Riga's East Clinical University Hospital Riga, Latvia		Riga			Latvia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms