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Clinical Evaluation of Opto-Acoustic Image Quality With the Gen 2 Imagio System

NCT05022602 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-03-29

Study results available
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Summary

This study performs the first clinical evaluation of the Gen 2 Imagio System in a clinical setting to assess image quality with both the IUS ultrasound only probe and the OA/US (duplex probe).

Conditions

  • Breast Cancer Stage

Interventions

DEVICE

Imagio

Imagio - both ultrasound probe and Duplex OA probe

Sponsors & Collaborators

  • American College of Radiology

    collaborator OTHER

  • Seno Medical Instruments Inc.

    lead INDUSTRY

Principal Investigators

  • Pam Otto, MD · UTHSC

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-19
Primary Completion
2022-02-17
Completion
2022-02-17
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05022602 on ClinicalTrials.gov