Immiseal™ Dural Sealant Post-Market Registry Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorMedprin Regenerative Medical Technologies Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Adult patients aged 18 to 75 years who require dural repair following neurosurgical procedures or traumatic injury and for whom the investigator has made the clinical decision to use the Immiseal™ Dural Sealant System as an adjunct to standard methods of dural repair. Eligible patients may have dural defects associated with craniocerebral trauma, brain tumour, cerebrovascular disease, congenital disease of the nervous system, posterior fossa surgery, spinal canal disease, or other neurosurgical procedures or accidents, and may present with or be at risk of cerebrospinal fluid leakage requiring auxiliary dural repair.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
85 Participants
are grouped into 1 trial groupGroup A: Patients Receiving Immiseal™ Dural Sealant System
Trial outcomes
Primary outcomes
1
Rate of Central Nervous System (CNS) Infection
Percentage of subjects with central nervous system infection up to 30 days post-operation, including bacterial meningitis, aseptic meningitis, and/or surgical site infection.
Time frame
Up to 30 days post-operationSecondary outcomes
1
Cerebrospinal Fluid (CSF) Leak Rate
Percentage of subjects with cerebrospinal fluid leak after primary dural repair using the Immiseal™ Dural Sealant System, used to assess effective watertight dural closure.
Time frame
Up to 100 ± 10 days post-operationOther outcomes
1
Meningitis Rate and Surgical Site Infection Rate Over the Study Period
Meningitis rate and surgical site infection rate will be observed over the course of the study. The analysis will be performed using Kaplan-Meier survival analysis over the whole follow-up period.
Time frame
Up to 100 ± 10 days post-operationSponsors and contacts
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Source ClinicalTrials.gov