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New device quickly stops bleeding in brain surgery

NCT ID NCT07199439

Disease control Sponsor: Medprin Regenerative Medical Technologies Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at a medical device called StypCel™ that helps stop bleeding during brain surgery. It included 108 patients between 18 and 75 years old. The main goal was to see how quickly the device stopped bleeding and to check its safety in real-world use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

108 people

The number who actually took part.

Started

Apr 2023

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Hemorrhage

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neurosurgery

Contacts and locations

Locations

  • Riga's East Clinical University Hospital Riga, Latvia

    Riga, Latvia

More trials for these conditions

Other studies related to the condition(s) this trial covers.