Intraoperative Brain Shift Calculation Study

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Intraoperative Brain Shift Calculation Study

Study Purpose

The purpose of the study is to calculate magnitude, type of intraoperative brain shift and assess possibility of it's prediction.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- all intracranial tumors.

- cavernomas.

- arteriovenous malformations.

- spontaneous (non-traumatic) intracerebral hemorrhages.

- traumatic intracerebral hemorrhages.

- supratentorial localization.

- newly diagnosed.

- age 18-100 years.

- stable hemodynamics.

- error of patient registration in neuronavigation no more than 2 mm.

Exclusion Criteria:

- rapid cerebral dislocation

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05477680
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sklifosovsky Institute of Emergency Care
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Alexander Dmitriev, MD
Principal Investigator Affiliation	Sklifosovsky Institute of Emergency Care
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Russian Federation
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Tumor, Brain, Cavernoma, Arteriovenous Malformations, Intracerebral Hematoma

Additional Details

Brain shift is the main natural cause of major navigation imprecision. Despite numerous attempts no trials showed a possibility to calculate and predict it's value although some patterns were found. Some modern navigational features allow to partially resolve this problem. Manual shift correction allows to displace brain structures but can only be used if brain shift is linear. Intraoperative computed tomography (CT) and magnetic resonance imaging (MRI) allow to update navigational data but violate surgical workflow and cannot display brain tissue in real time. Intraoperative sonography has poorer quality, limited observe volume and lengthy learning curve. The purpose of the study is to calculate magnitude, type of intraoperative brain shift and assess possibility of it's prediction. For each patient a surgeon intraoperatively will assess location of brain surface, various intracranial structures and lesion margins during surgery. Postoperatively these data will be compared to lesion's characteristics, patient's state and intraoperative features.

Arms & Interventions

Arms

Experimental: Surgery

Removing different brain lesions using neuronavigation

Interventions

Device: - Navigation-guided surgery

Surgeon removes brain lesions and assesses brain shift with neuronavigation

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.