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Immiseal™ Dural Sealant Post-Market Registry Study

NCT07651826 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 85

Last updated 2026-06-16

No results posted yet for this study

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

Sponsors & Collaborators

  • Medprin Regenerative Medical Technologies Co., Ltd.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-17
Primary Completion
2026-08-15
Completion
2026-11-23

Countries

  • Latvia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07651826 on ClinicalTrials.gov