NCT05022602

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Seno Medical Instruments Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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))

Conditions

• Breast Cancer Stage

Interventions

Type	Name	Description
DEVICE	Imagio	Imagio - both ultrasound probe and Duplex OA probe

Timeline

• Start date: 2021-08-19
• Primary completion: 2022-02-17
• Completion: 2022-02-17
• First posted: 2021-08-26
• Last updated: 2023-03-29
• Results posted: 2023-03-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study