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

August 27, 2024 updated by: MDCECRO LLC

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

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 will monitor the device's safety and effectiveness in real-world conditions across multiple sites. It will include 108 patients who require the device during neurosurgery and will observe the time it takes to achieve hemostasis and track any complications, including infections and other serious adverse events. The study aims to ensure the continued safety and effectiveness of the device after it has been introduced to the market.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The StypCel™ Absorbable Hemostat is designed to control bleeding during neurosurgical procedures. This PMCF study is an observational, multicenter investigation that will include 108 patients across up to 8 medical sites. The study's 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. The study will help to confirm the safety and performance of the StypCel™ device in everyday clinical use and ensure it meets the required standards for patient safety. 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.

Study Type

Observational

Enrollment (Actual)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Latvia
      • Riga, Latvia
        • Riga's East Clinical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: StypCel™ Absorbable Hemostat
The StypCel™ Absorbable Hemostat is used during neurosurgery to control bleeding. It is applied directly to the bleeding site to achieve hemostasis within a few minutes. The study will observe its effectiveness and any related complications during and after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Hemostasis
Time Frame: 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. Hemostasis is defined as the cessation of bleeding without the need for additional interventions.
During surgery (typically within 5 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Intracranial Infections
Time Frame: 10 days and 6 months post-surgery
The secondary outcome is the incidence of intracranial infections occurring within 10 days and 6 months after surgery where the StypCel™ Absorbable Hemostat was used.
10 days and 6 months post-surgery
Rate of Serious Adverse Events
Time Frame: 6 months post-surgery
The secondary outcome is the incidence of any serious adverse events related to the use of the StypCel™ Absorbable Hemostat within the 6-month follow-up period.
6 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MDCECRO LLC

Collaborators

Medprin Regenerative Medical Technologies Co., Ltd.

Investigators

  • Study Director: Yuchuan Zhang, Dr., Medprin Regenerative Medical Technologies Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2023

Primary Completion (Actual)

April 25, 2024

Study Completion (Estimated)

September 15, 2024

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • MP-RD05-92

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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