Immiseal™ Dural Sealant Post-Market Registry Study

Multicentre, Prospective, Post-Market, Observational Registry Study to Observe the Performance and Safety of the Immiseal™ Dural Sealant System for Use as an Adjunct to Standard Methods of Dural Repair to Provide Watertight Closure During Neurosurgical Procedures

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07651826

Enrollment

Registered

2026-06-16

Start date

2026-02-17

Completion date

2026-11-23

Last updated

2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrospinal Fluid Leak, Dural Defect, Neurosurgical Procedures

Keywords

Immiseal, Dural sealant, Dural repair, Cerebrospinal Fluid Leak, Surgical site infection, Post-market clinical follow-up, Dural Defect, Neurosurgical Procedure

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Rate of Central Nervous System (CNS) Infection	Up to 30 days post-operation	Percentage of subjects with central nervous system infection up to 30 days post-operation, including bacterial meningitis, aseptic meningitis, and/or surgical site infection.

Secondary

Measure	Time frame	Description
Cerebrospinal Fluid (CSF) Leak Rate	Up to 100 ± 10 days post-operation	Percentage of subjects with cerebrospinal fluid leak after primary dural repair using the Immiseal™ Dural Sealant System, used to assess effective watertight dural closure.

Countries

Latvia

Contacts

CONTACTYuchuan Zhang

zhangyuchuan@medprin.com+86 20 32296118

CONTACTXiaoting Liao

liaoxiaoting@medprin.com+86 15602300416

Outcome results