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Imagio Feasibility Multi-Reader, Multi-Case Study

NCT03708393 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2021-08-06

Study results available
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Summary

Controlled, blinded, multi-reader, multi-case study

Conditions

Interventions

DEVICE

Imagio (IUS+OA)

The Imagio ultrasound and opto-acoustic images to be reviewed as part of the reader study

DEVICE

Imagio Ultrasound

Imagio ultrasound images to be reviewed as part of the reader study

DEVICE

Mammography

Mammography images as available per standard of care

Sponsors & Collaborators

  • American College of Radiology

    collaborator OTHER

  • Seno Medical Instruments Inc.

    lead INDUSTRY

Principal Investigators

  • A. Thomas Stavros, MD · Seno Medical

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-13
Primary Completion
2018-12-09
Completion
2018-12-09
FDA Device
Yes

Countries

  • United States

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 NCT03708393 on ClinicalTrials.gov