Immiseal™ Dural Sealant Post-Market Registry Study
Latvia85 participantsStarted 2026-02-17
Plain-language summary
This is a multicentre, prospective, open-label, single-arm, observational, post-market clinical follow-up registry study designed to observe the safety and performance of the Immiseal™ Dural Sealant System when used as an adjunct to standard methods of dural repair to provide watertight closure during neurosurgical procedures. Eligible adult subjects requiring dural repair after neurosurgical procedures or traumatic injury, for whom the investigator has made the clinical decision to use the device, will be enrolled and followed for approximately 100 ± 10 days after surgery.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18 to 75 years old, regardless of gender.
. Patients diagnosed with craniocerebral trauma, brain tumour, cerebrovascular disease, congenital disease of the nervous system, or spinal canal disease, who undergo neurosurgical procedures such as posterior fossa surgery or other interventions resulting in dural defects, whether due to surgery or accidental injury, and who present with, or are at risk of, cerebrospinal fluid (CSF) leakage requiring auxiliary dural repair.
. Patients willing to comply with the requirements of the clinical investigation by signing the informed consent.
. Female patients of childbearing potential must use highly effective contraceptive methods for the duration of the study. Highly effective contraceptive methods include hormonal contraception, intrauterine device, or sexual abstinence.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a post-market registry study for Immiseal™ as a dural sealant, does that mean the device is already approved and in use, and if so, how does that affect what's known about its safety compared to earlier research stages?
2The main thing being tracked in this study is the rate of CNS infections after the sealant is used — how does that risk compare to other dural sealant options or the standard approach used during my type of neurosurgery?
3Would I be receiving Immiseal™ as part of my standard surgical care regardless of this registry, or does joining this study change anything about my actual treatment?
4What kind of follow-up or data collection would be required of me if I participate in this registry, and how might that fit into my recovery schedule after neurosurgery?
5Are there alternative dural sealant products or closure techniques already well-studied that you'd consider first for my situation, and what would make Immiseal™ a better or worse fit for me specifically?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of Central Nervous System (CNS) Infection
Timeframe: Up to 30 days post-operation
Trial details
NCT IDNCT07651826
SponsorMedprin Regenerative Medical Technologies Co., Ltd.
. Immiseal™ Dural Sealant System is not to be used in confined bone structures where nerves are present, since neural compression may result due to hydrogel swelling.
. Patients with an active infection present at the surgical site.
. Patients with life expectancy less than 3 months.
. Female patients who are pregnant, planning pregnancy, breastfeeding, and/or unwilling to use adequate contraception during the trial.