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Dynamic Decompressive Craniotomy | Clinical Trials | Clareo Health

UNKNOWN

Dynamic Decompressive Craniotomy

NCT05051488•Rohit Khanna, MD

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Key Dates

Start Date

April 30, 2022

Primary Completion Date

December 30, 2022

Completion Date

December 30, 2023

Last Updated

April 6, 2022

Enrollment

ESTIMATED participants

Conditions

Brain EdemaTBI (Traumatic Brain Injury)Stroke, AcuteCerebral HemorrhageBrain Tumor

Interventions

Dynamic craniotomy

PROCEDURE

Dynamic craniotomy

DEVICE

Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury

NCT06467708

TBI (Traumatic Brain Injury)

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RECRUITINGPHASE3

Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke

NCT06658197

Stroke, IschemicStroke, Acute+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 6, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Dynamic Decompressive Craniotomy

Inclusion Criteria

Exclusion Criteria

Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury

Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke

Early Neurological Clinical Recovery, 3 Months After Endovascular Treatment of an Acute Ischemic Stroke

Validation of Early Prognostic Data for Recovery Outcome After Stroke for Future, Higher Yield Trials

Long-Term Outcomes of LAA Contrast Flow in CT Scans After Endocardial LAA Closure: The CF-CT Registry

Hospital Implementation of a Stroke Protocol for Emergency Evaluation and Disposition