Dynamic Decompressive Craniotomy

NeuroVention

Status: Unknown

Conditions: Cerebral Hemorrhage; Brain Edema; Brain Tumor; Stroke, Acute; TBI (Traumatic Brain Injury)

Treatments: Device: Dynamic craniotomy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05051488

1

Details and patient eligibility

About

Prospective observational study on patients undergoing decompressive craniotomy

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing craniotomy who are at an increased risk for developing post- operative brain swelling or increased intracranial pressure from a malignant stroke
• Patients undergoing craniotomy who are at an increased risk for developing post- operative brain swelling or increased intracranial pressure from traumatic brain injury
• Patients undergoing craniotomy who are at an increased risk for developing post- operative brain swelling or increased intracranial pressure from brain tumors.

Exclusion criteria

• Patients with blown pupil (cerebral herniation),
• Massive brain swelling
• Dismal outcome not expected to survive more than 1-2 weeks.