NCT05051488

Dynamic Decompressive Craniotomy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Rohit Khanna, MD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective observational study on patients undergoing decompressive craniotomy

Detailed 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.

Conditions

• Brain Edema
• TBI (Traumatic Brain Injury)
• Stroke, Acute
• Cerebral Hemorrhage
• Brain Tumor

Interventions

Type	Name	Description
PROCEDURE	Dynamic craniotomy	Dynamic decompressive craniotomy with semi-rigid bone flap fixation
DEVICE	Dynamic craniotomy	Dynamic decompressive craniotomy with semi-rigid bone flap fixation

Timeline

• Start date: 2022-04-30
• Primary completion: 2022-12-30
• Completion: 2023-12-30
• First posted: 2021-09-21
• Last updated: 2022-04-06

Regulatory

• FDA-regulated device study