NeurosurgeryPMCFStypcelNCT07199439
Post-market Clinical Follow-up Plan of StypCel™ Absorbable Hemostat
An observational study of Neurosurgery, run by Medprin Regenerative Medical Technologies Co., Ltd. at 1 site in Latvia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neurosurgery
- How many people
- 108 participants
- Where
- 1 siteLatvia
- Study dates
- 23 Apr 2023to 15 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 include 108 patients . The aim of the study is to furtherly assess the safety and performance of the device under the real-word setting
Read the 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.
- Conditions
- Neurosurgery
- Keywords
- bleeding
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during surgery (typically within 5 minutes）
Time to Hemostasis
Time to Hemostasis within 5 minutes
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start23 Apr 2023
- Primary completion25 Apr 2023
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurosurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MDCECRO LLC
- Responsible party
- Sponsor
- Investigators
- Kaspars Auslands, Dr., Principal investigator, Riga's East Clinical University Hospital Riga, Latvia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199439
- Sponsor's protocol ID
- MP-RD05-092
- Other IDs
- 270323 - 4E
- Acronym
- PMCFStypcel
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Prospective, Post Market Observational Registry Study to Observe the Performance and Safety of the StypCel™ Device to Achieve Hemostasis During Neurosurgery
- ClinicalTrials.gov ID
- NCT07199439
- Acronym / sponsor ID
- PMCFStypcel / MP-RD05-092
- Conditions
- Neurosurgery
- Keywords
- bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- MDCECRO LLC
- Study start
- 23 Apr 2023 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to Hemostasis within 5 mins
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.
Time to Hemostasis
Time frame: During surgery
Time to Hemostasis within 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaspars Auslands, Dr. principal investigator
Riga's East Clinical University Hospital Riga, Latvia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurosurgery, run by Medprin Regenerative Medical Technologies Co., Ltd. at 1 site in Latvia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Hemostasis within 5 mins (time frame: during surgery (typically within 5 minutes）). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.