CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 217 enrolled
Drug / intervention
Imagio IUS +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02364388
NCT02364388N/ACompleted
CompareCT.gov

IMAging With Opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO Other Diagnostic Methodologies (MAESTRO)

Seno Medical Instruments Inc.·interventional·Posted Feb 18, 2015·Updated Apr 6, 2020

In Brief

A clinical study evaluating Imagio IUS and Imagio OA/US for Breast Cancer. Completed, enrolled 217 participants across 5 sites.

Detailed Summary

Imagio breast imaging system, is an opto-acoustic (OA) imaging system designed to concurrently collect images in conjunction with diagnostic ultrasound ( co-registered OA and B-mode imaging). This medical device has CE-marking and is approved for use in Europe and other nations. This is a post-market, non-randomized multi-center surveillance study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesNetherlands
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 18, 2015
Enrollment StartMar 27, 2015
Primary CompletionFeb 15, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.4 years ago

Interventions

Imagio IUSdevice

Imagio diagnostic gray-scale ultrasound

Imagio OA/USdevice

Diagnostic opto-acoustic +gray-scale ultrasound