Intraoperative Brain Shift Calculation Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorSklifosovsky Institute of Emergency Care
About this trial
The purpose of the study is to calculate magnitude, type of intraoperative brain shift and assess possibility of it's prediction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
all intracranial tumors
cavernomas
arteriovenous malformations
spontaneous (non-traumatic) intracerebral hemorrhages
Disqualifiers
rapid cerebral dislocation
Trial design
Design model
Single group
Treatments tested in this trial
Navigation-guided surgery
DeviceSurgeon removes brain lesions and assesses brain shift with neuronavigation
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: SurgeryExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Brain shift (in millimeters)
Maximal difference between disposition of different brain structures in preoperative scans and it's real intraoperative location
Time frame
IntraoperativelySecondary outcomes
1
Karnofsky Performance status in percents
Assesses patients' possibilities to self-service
Time frame
within 10 days after surgery2
Cerebral complications
Which cerebral complications arose after surgery
Time frame
From admission to intensive care unit after surgery till hospital discharge, up to 365 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov