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Immiseal™ Dural Sealant Post-Market Registry Study
Sponsor: Medprin Regenerative Medical Technologies Co., Ltd.
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.
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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
85
Start Date
2026-02-17
Completion Date
2026-11-23
Last Updated
2026-06-16
Healthy Volunteers
No
Locations (1)
Riga East Clinical University Hospital
Riga, Latvia