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Optoacoustic Images Versus Imagio® Ultrasound

NCT04030104 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2021-07-12

Study results available
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Summary

The Imagio® Pivotal Study is intended to evaluate if the results observed in the previous Feasibility Study can be confirmed for pre-specified effectiveness endpoints. Using Intention-to-Diagnose (ITD) masses from the PIONEER Pivotal study, 480 to 840 masses are to be used for the Pivotal Study, the remaining masses will be reserved for training the SenoGram® model.

Conditions

Interventions

DEVICE

Reader Study - Imagio Ultrasound

Imagio ultrasound images to be reviewed as part of Reader study

DEVICE

Reader Study Imagio Ultrasound + Optoacoustic Imaging

Imagio Ultrasound + Optoacoustic images to be reviewed as part of Reader study

DEVICE

Mammography

Mammography as available per standard of care

Sponsors & Collaborators

  • Seno Medical Instruments Inc.

    lead INDUSTRY

Principal Investigators

  • Shaan Schaeffer · 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
2019-07-30
Primary Completion
2019-11-03
Completion
2019-11-03
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 NCT04030104 on ClinicalTrials.gov