NCT02902328

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

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

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

March 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

6 months

First QC Date

September 12, 2016

Last Update Submit

September 12, 2016

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Validation of the accurate visualization of brain structures based on SIS algorithms

    one year

Study Arms (1)

MRI data collection

A group of 30 subjects will be scanned on a 3 Tesla (T) and on a 7T MRI scanners. The images will be compared.

Eligibility Criteria

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

A cohort of 30 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 Design

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

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 15, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 15, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share