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The PIONEER-01 Study of the Imagio Breast Imaging System

NCT01943916 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2105

Last updated 2023-02-08

Study results available
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Summary

This is a prospective controlled multi-center study involving gray scale (B-mode) ultrasound vs OA/US (opto-acoustic and gray scale ultrasound) for the visualization of suspicious masses. Imagio gray scale and OA image sets will be collected on each enrolled mass and pushed to an Imaging Core Lab for processing and then to a set of Independent Readers who will read the Imagio gray-scale images vs the Imagio OA/US images.

Conditions

Interventions

DEVICE

Imagio OA/US (US and OA/US)

opto-acoustic plus gray scale ultrasound

DEVICE

Imagio gray scale ultrasound

gray scale ultrasound alone

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
2012-12-21
Primary Completion
2015-09-09
Completion
2015-09-09

Countries

  • United States

Study Locations

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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 NCT01943916 on ClinicalTrials.gov