Condition: Dural Defect · Cerebrospinal Fluid Leak · Neurosurgical Procedures · Sponsor: Medprin Regenerative Medical Technologies Co., Ltd.
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.
This description comes directly from the study's public registry record.
Yuchuan Zhang · +86 20 32296118 · zhangyuchuan@medprin.com
Xiaoting Liao · +86 15602300416 · liaoxiaoting@medprin.com
Always discuss trial participation with your own doctor first.
| Riga East Clinical University Hospital | Riga, Latvia | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07651826