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OpenTrials
Completed

NCT Number: NCT02902328

Accuracy Evaluation for SIS Software-based Visualization of Anatomical Brain Structures

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

A cohort of 30 subjects will be scanned on a clinical MRI scanner as well as on a 7 Tesla (T) 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 of the same subject obtained from the 7T MRI.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all subject that are willing to be scanned on a 3T and 7T MRI scanners and are not excluded by the exclusion criteria below.

Exclusion criteria

  • MRI exclusion criteria for 7T scans: presence of any metallic clip(s) or implantable medical devices (e.g., heart valve, aneurysm clip, coils or surgery, renal or aortic clips, shunts, stents or stent grafts, metal mesh/coil implants, neurostimulator, insulin pump, IVC filter, artificial knee or hip, metal plates, pins, screws or wires anywhere in the body, any other metal implants, etc.).
  • Pregnant women.
  • Subject under the age of 18

Treatment and study plan

Primary outcomes

  1. Validation of the accurate visualization of brain structures based on SIS algorithms

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Surgical Information Sciences Inc.

Industry

Registry information

Official study title

Accuracy Evaluation for Software-based Visualization of Anatomical Brain Structures Using Surgical Information Sciences Inc. Algorithms

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 15, 2016
Registry last updated
Sep 15, 2016

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.