Sklifosovsky Institute of Emergency Care
Moscow, 129090, Russia
Location status: Recruiting
NCT Number: NCT05477680
The purpose of the study is to calculate magnitude, type of intraoperative brain shift and assess possibility of it's prediction.
Interested in participating?
Request Info18 year–100 year
All sexes
Interventional
Not applicable
Moscow, 129090, Russia
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgeon removes brain lesions and assesses brain shift with neuronavigation
Time frame: Intraoperatively
Maximal difference between disposition of different brain structures in preoperative scans and it's real intraoperative location
Time frame: within 10 days after surgery
Assesses patients' possibilities to self-service
Time frame: From admission to intensive care unit after surgery till hospital discharge, up to 365 days
Which cerebral complications arose after surgery
Contact information is provided by the study sponsor or research team.
Sklifosovsky Institute of Emergency Care
Other Gov
Intraoperative Brain Shift Calculation Study: a Prospective, Single Arm Clinical Trial
Acronym: BRASH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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