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Brain-Shift Monitoring Using 3D Scanning

NCT05018338 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2025-10-02

No results posted yet for this study

Summary

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.

Conditions

  • Craniotomy for Epilepsy and Malignant Tumor Removal

Interventions

DEVICE

Brain shift monitoring

For use to monitor brain shift during craniotomy

Sponsors & Collaborators

  • Advanced Scanners Inc.

    lead INDUSTRY

Principal Investigators

  • Aaron Bernstein, PhD · Advanced Scanners Inc.

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-28
Primary Completion
2020-02-28
Completion
2020-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05018338 on ClinicalTrials.gov