NCT04814277

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 26, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2021

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

March 19, 2021

Last Update Submit

November 21, 2023

Conditions

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

Outcome Measures

Primary Outcomes (3)

  • Validation of the accurate visualization of brain structure based on SIS algorithms - 1

    Difference in distance between brain structure center of mass (COM)

    Through study completion, up to 1 year

  • Validation of the accurate visualization of brain structure based on SIS algorithms - 2

    Difference in distance between brain structure mean surface area

    Through study completion, up to 1 year

  • Validation of the accurate visualization of brain structure based on SIS algorithms - 3

    Difference in Dice Coefficient between measured brain structures

    Through study completion, up to 1 year

Study Arms (1)

MRI Data Collection

A group of 34 subjects will be scanned on a 3Tesla (3T) and on a 7T MRI scanner. The images will be compared.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A cohort of 34 adults who will be scanned on a 3T and 7T MRI to obtain anatomical images of their brain.

You may not qualify if:

  • Pregnant women.
  • Subject under the age of 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surgical Information Sciences

Plymouth, Minnesota, 55441, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2021

First Posted

March 24, 2021

Study Start

October 26, 2020

Primary Completion

January 5, 2021

Study Completion

January 11, 2021

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)