Dural DefectNCT07651826
Immiseal™ Dural Sealant Post-Market Registry Study
An observational study of Dural Defect and Cerebrospinal Fluid Leak, run by Medprin Regenerative Medical Technologies Co., Ltd. at 1 site in Latvia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dural Defect, Cerebrospinal Fluid Leak, Neurosurgical Procedures
- How many people
- 85 participants
- Where
- 1 siteLatvia
- Study dates
- 17 Feb 2026to 23 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Latvia1 site, 1 recruiting
- Recruiting
Riga East Clinical University Hospital
Riga
Auslands Prof Dr. Kaspars Auslands, +37 122018891, Kaspars.Auslands@rsu.lv
About this study
Official title: 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
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.
- Keywords
- Immiseal, Dural sealant, Dural repair, Cerebrospinal Fluid Leak, Surgical site infection, Post-market clinical follow-up, Dural Defect, Neurosurgical Procedure
- Medical subject headings
- Cerebrospinal Fluid Leak, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients Receiving Immiseal™ Dural Sealant System | Adult patients requiring dural repair following neurosurgical procedures or traumatic injury, 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. Subjects will be followed for safety and device performance outcomes through approximately 100 ± 10 days post-operation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 days post-operation
Secondary 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.
Measured: Up to 100 ± 10 days post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start17 Feb 2026
- Primary completion15 Aug 2026 (estimated)
- Study completion23 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dural DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651826
- Sponsor's protocol ID
- MP-RD08-49
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07651826
- Acronym / sponsor ID
- MP-RD08-49
- Keywords
- Immiseal, Dural sealant, Dural repair, Cerebrospinal Fluid Leak, Surgical site infection, Post-market clinical follow-up, Dural Defect, Neurosurgical Procedure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 23 Nov 2026 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Receiving Immiseal™ Dural Sealant System | – | –Adult patients requiring dural repair following neurosurgical procedures or traumatic injury, 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. Subjects will be followed for safety and device performance outcomes through approximately 100 ± 10 days post-operation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of Central Nervous System (CNS) Infection
Time frame: 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.
1 secondary outcome
Cerebrospinal Fluid (CSF) Leak Rate
Time frame: Up to 100 ± 10 days post-operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dural Defect and Cerebrospinal Fluid Leak, run by Medprin Regenerative Medical Technologies Co., Ltd. at 1 site in Latvia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuchuan Zhang (+86 20 32296118, zhangyuchuan@medprin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Central Nervous System (CNS) Infection (time frame: Up to 30 days post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.