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Accuracy Evaluation of SIS Software-based Visualization of New Anatomical Brain Structure

Accuracy Evaluation for Software-based Visualization of GPi/GPe Anatomical Brain Structure Using Surgical Information Sciences Inc. Algorithms

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04814277
Enrollment
34
Registered
2021-03-24
Start date
2020-10-26
Completion date
2021-01-11
Last updated
2023-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Software Evaluation for Visualizing Anatomical Structures Not Typically Identified on Clinical MR Images

Brief summary

SIS has developed a software technology, based on machine learning and image processing, designed to enhance standard clinical images for the visualization of anatomical structures.

Detailed description

A cohort of 34 subjects will be scanned on a clinical MRI scanner as well as on a 7 Tesla (7T) scanner. Images acquired on the 7T allow to visualize anatomical structures that are not easily identified on standard clinical images. SIS software will be used to visualize selected anatomical features on the clinical image and the results will be compared with the images in the same subject obtained from the 7T MRI.

Interventions

None listed

Sponsors

Surgical Information Sciences Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* All subjects that are willing to be scanned on a 3T and 7T MRI scanners and are not excluded by the

Exclusion criteria

below.

Design outcomes

Primary

MeasureTime frameDescription
Validation of the accurate visualization of brain structure based on SIS algorithms - 1Through study completion, up to 1 yearDifference in distance between brain structure center of mass (COM)
Validation of the accurate visualization of brain structure based on SIS algorithms - 2Through study completion, up to 1 yearDifference in distance between brain structure mean surface area
Validation of the accurate visualization of brain structure based on SIS algorithms - 3Through study completion, up to 1 yearDifference in Dice Coefficient between measured brain structures

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026