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Clinical Trial Summary

Prospective observational study on patients undergoing decompressive craniotomy


Clinical Trial Description

A prospective study of 20 neurosurgical patients evaluating the dynamic decompressive craniotomy technique using NeuroVention, LLC craniotomy bone flap fixation plates. The plates allow for rigid and semi-rigid bone flap fixation dependent on the implantation technique. A dynamic craniotomy involves bone flap fixation wherein a limited transient outward bone flap movement is allowed by the plates to compensate for an increase in intracranial pressure from brain swelling. The plates also prevent the craniotomy bone flap from sinking inside the skull and compressing on the brain. Cerebral decompression surgery is undertaken for patients with cerebral swelling from malignant strokes, medically intractable intracranial pressure elevation in traumatic brain injuries and brain tumors. The dynamic craniotomy technique eliminates or reduces the need for a cranioplasty surgery with a potentially significant improvement in outcome. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05051488
Study type Observational
Source NeuroVention, LLC
Contact
Status Not yet recruiting
Phase
Start date April 30, 2022
Completion date December 30, 2023

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