NCT05018338|TerminatedFDA Device
Study Stopped
Low enrollment of subjects
Brain-Shift Monitoring Using 3D Scanning
Pre-pilot Study of Brain-Shift Monitoring Using 3D Scanning
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Sponsor study identifier
observational
1
1 country
1
Study Start
February 28, 2020
Actual (reported)Primary Completion
February 28, 2020
Actual (reported)Study Completion
February 28, 2020
Actual (reported)A prospective non-invasive data/image collection for evaluation of the performance of the Advanced Scanners 3D scanner during brain surgery. The primary objective is to evaluate the performance of the scanner in determining the brain surface shape over multiple time points during craniotomies (surgical opening into the skull), and present those shapes in full color, with high resolution in all three coordinates of 3D space. A secondary objective is to use the measurements to determine brain shift as a function of time.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 28, 2020
Actual (reported)February 28, 2020
Actual (reported)February 28, 2020
Actual (reported)August 18, 2021
Actual (reported)August 24, 2021
Actual (reported)Brain-shift measurement
Measure brain-shift in human subjects' brains with our scanning technology, and compare with preoperative MRI or CT, and, optionally, with inter-operative or postoperative MRI or CT scans. Measurements will include changes, measured in millimeters, of the surface anatomic features of the brain from the optical scans. Overall topological changes will also be measured between pre- and post-operative CT/MRI imaging of the patient with the optical scans. All these measurements will be performed using co-registered surfaces, reporting specifically computer-determined measurement of distances between those surfaces.
Throughout the surgical procedure
Brain-shift measurement accuracy
Throughout the surgical procedure
Operation of the 3D scanner
Throughout the surgical procedure
The study will enroll 10 subjects meeting the eligibility criteria, with the expectation to obtain complete data from at least 6 subjects.
For use to monitor brain shift during craniotomy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Subjects seen by Dr. Anat I. Patel (neurosurgeon) and scheduled for craniotomy at St. David's North Austin Medical Center are the potential population for this study.
St. David's Medical Center
Austin, Texas, 78758, United States
Daanen, H. A. M. & Ter Haar, F. B. 3D whole body scanners revisited. Displays 34, 270-275 (2013).
Yang, J. C. et al., Journal of Clinical Neuroscience 21, p. 1230 (2014) and Mert, A. et al, Operative Neurosurgery 71, p. 286 (2012), respectively.
Zhang, D., Lu, G., Li, W., Zhang, L. & Luo, N. Palmprint Recognition Using 3-D Information. IEEE Transactions on Systems, Man, and Cybernetics, Part C (Applications and Reviews) 39, 505-519 (2009).
Park HK, Chung JW, Kho HS. Use of hand-held laser scanning in the assessment of craniometry. Forensic Sci Int. 2006 Jul 13;160(2-3):200-6. doi: 10.1016/j.forsciint.2005.10.007. Epub 2005 Nov 9.
Aaron Bernstein, PhD
Advanced Scanners Inc.
1 participants (actual enrollment reported by the registry).
First Submitted
August 18, 2021
First Posted
August 24, 2021
Study Start
February 28, 2020
Actual (reported)Contact the study team to confirm eligibility.
Kovacs L, Zimmermann A, Brockmann G, Guhring M, Baurecht H, Papadopulos NA, Schwenzer-Zimmerer K, Sader R, Biemer E, Zeilhofer HF. Three-dimensional recording of the human face with a 3D laser scanner. J Plast Reconstr Aesthet Surg. 2006;59(11):1193-202. doi: 10.1016/j.bjps.2005.10.025. Epub 2006 Mar 9.
Hameeteman M, Verhulst AC, Vreeken RD, Maal TJ, Ulrich DJ. 3D stereophotogrammetry in upper-extremity lymphedema: An accurate diagnostic method. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):241-7. doi: 10.1016/j.bjps.2015.10.011. Epub 2015 Oct 22.
Arlt F, Chalopin C, Muns A, Meixensberger J, Lindner D. Intraoperative 3D contrast-enhanced ultrasound (CEUS): a prospective study of 50 patients with brain tumours. Acta Neurochir (Wien). 2016 Apr;158(4):685-694. doi: 10.1007/s00701-016-2738-z. Epub 2016 Feb 16.
Primary Completion
February 28, 2020
Actual (reported)Study Completion
February 28, 2020
Actual (reported)Last Updated
October 2, 2025
Record last verified: 2025-09
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Source: ClinicalTrials.gov.
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