CompletedNCT02902328Updated Sep 15, 2016

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

An observational study in Software Evaluation for Visualizing Anatomical Structures That Are Not Typically Identified on Clinical MR Images, sponsored by Surgical Information Sciences Inc.. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-15.

Sponsored by Surgical Information Sciences Inc. · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 30
Ages: 18 Years and older
Sex: All

Study 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.

Read the detailed description

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.

Conditions studied

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

In context

Lead sponsor

Surgical Information Sciences Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Probability 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 30 participants (actual)
Patient registry: No

Groups and cohorts

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.

What researchers measure

Primary outcomes

Validation of the accurate visualization of brain structures based on SIS algorithms
Time frame: one year

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2016, a primary completion of Sep 2016 and a completion of Sep 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 12, 2016
First posted: Sep 15, 2016
Start: Mar 2016
Primary completionActual: Sep 2016
CompletionActual: Sep 2016
Last update: Sep 15, 2016

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Sep 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02902328
Lead sponsor: Surgical Information Sciences Inc.
Responsible party: Sponsor
First posted: Sep 15, 2016
Start date: Mar 2016
Primary completion: Sep 2016
Completion: Sep 2016
Last update: Sep 15, 2016

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Other studies from this sponsor

Surgical Information Sciences Inc.

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