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Clinical Trial 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).


Clinical Trial Description

1. Obtain ultrasound only probe images and duplex probe OA/US (both gray scale and OA) probe images. This includes doppler and elastography imaging with the gray scale only ultrasound probe and ultrasound mode of the duplex OA/US probe. 2. Provide breast and lymph node pathology results (except BI-RADS 1, 2 and 3 (as applicable)) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05022602
Study type Interventional
Source Seno Medical Instruments Inc.
Contact
Status Completed
Phase N/A
Start date August 19, 2021
Completion date February 17, 2022

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