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RECRUITING
NCT07651826

Immiseal™ Dural Sealant Post-Market Registry Study

Sponsor: Medprin Regenerative Medical Technologies Co., Ltd.

View on ClinicalTrials.gov

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