Dural Sealant Used After Neurosurgery to Help Ensure Watertight Closure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective, open-label registry collects post-market data on the Immiseal Dural Sealant System used as an adjunct to standard dural repair in neurosurgery. Eligible adults who require dural repair due to surgery or injury are enrolled and followed for about 100 days after surgery to monitor safety and performance. The study observes outcomes in routine clinical practice to understand real-world use and potential signals of benefit or risk. As an observational registry, there is no randomization or control group.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18 to 75 years old, regardless of gender.
2. 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.
3. Patients willing to comply with the requirements of the clinical investigation by signing the informed consent.
4. 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:

1. 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.
2. Patients with an active infection present at the surgical site.
3. Patients with life expectancy less than 3 months.
4. Female patients who are pregnant, planning pregnancy, breastfeeding, and/or unwilling to use adequate contraception during the trial.

Where it's running

• Riga East Clinical University Hospital
  Riga, Latvia Recruiting

Study contacts

• Study coordinator: Yuchuan Zhang
• Email: zhangyuchuan@medprin.com
• Phone: +86 20 32296118

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Registry for spontaneous intracranial hypotension and post-dural puncture headache

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• Understanding post‑cardiac arrest brain injury through spinal fluid molecular analysis

  This project will test whether detailed molecular analysis of spinal fluid from people who had a cardiac arrest can reveal targets for new treatments.

  Recruiting Chungnam National University Hospital · Daejeon, Jung-gu · NCT07481396

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.