Immiseal™ Dural Sealant Post-Market Registry Study

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.

NCT Number	NCT07651826
Lead Sponsor	Medprin Regenerative Medical Technologies Co., Ltd.
Conditions	Dural Defect, Cerebrospinal Fluid Leak, Neurosurgical Procedures
Enrollment	85 participants
Start Date	2026-02-17
Primary Completion	2026-08-15 (estimated)
Study Completion	2026-11-23 (estimated)
Updated on ClinicalTrials.gov	2026-06-16