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

NCT02364388 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2020-04-06

Study results available
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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.

Conditions

Interventions

DEVICE

Imagio IUS

Imagio diagnostic gray-scale ultrasound

DEVICE

Imagio OA/US

Diagnostic opto-acoustic +gray-scale ultrasound

Sponsors & Collaborators

  • Seno Medical Instruments Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-27
Primary Completion
2016-02-15
Completion
2016-02-15

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02364388 on ClinicalTrials.gov