Immiseal™ Dural Sealant Post-Market Registry Study

NCT07651826 | Recruiting

• 1 other identifier: MP-RD08-49
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Dural Defect; Cerebrospinal Fluid Leak; Neurosurgical Procedures

Keywords

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

Outcome Measures

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.

  Up to 30 days post-operation

Secondary Outcomes (1)

• Cerebrospinal Fluid (CSF) Leak Rate

  Up to 100 ± 10 days post-operation

Other Outcomes (1)

• Meningitis Rate and Surgical Site Infection Rate Over the Study Period

  Up to 100 ± 10 days post-operation

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medprin Regenerative Medical Technologies Co., Ltd.: lead

Study Sites (1)

Riga East Clinical University Hospital

Riga, Latvia

RECRUITING

MeSH Terms

Conditions

Cerebrospinal Fluid Leak; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Wound Infection; Infections; Postoperative Complications; Pathologic Processes

Central Study Contacts

Yuchuan Zhang

CONTACT

+86 20 32296118; zhangyuchuan@medprin.com

Xiaoting Liao

CONTACT

+86 15602300416; liaoxiaoting@medprin.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start: February 17, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): November 23, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1)