Trial Outcomes & Findings for Clinical Evaluation of Opto-Acoustic Image Quality With the Gen 2 Imagio System (NCT NCT05022602)

Last Updated: 2023-03-29

Results Overview

Obtain ultrasound only probe images and OA/US (both gray scale and OA) probe images as measured by the receipt of image sets for each subject enrolled.

Recruitment status

COMPLETED

Study phase

Target enrollment

38 participants

Primary outcome timeframe

Baseline

Results posted on

2023-03-29

Participant Flow

Participant milestones

Participant milestones
Measure	Imagio Imagio Grayscale only probe and Imagio Duplex probe in ultrasound only and OA modes Imagio: Imagio - both ultrasound probe and Duplex OA probe
Overall Study STARTED	38
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Imagio n=38 Participants Imagio Grayscale only probe and Imagio Duplex probe in ultrasound only and OA modes Imagio: Imagio - both ultrasound probe and Duplex OA probe
Age, Continuous	44.3 Years STANDARD_DEVIATION 15.41 • n=99 Participants
Sex: Female, Male Female	38 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	3 Participants n=99 Participants
Race (NIH/OMB) White	34 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Region of Enrollment United States	38 participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline

Obtain ultrasound only probe images and OA/US (both gray scale and OA) probe images as measured by the receipt of image sets for each subject enrolled.

Outcome measures

Outcome measures
Measure	Imagio n=38 Participants Imagio Grayscale only probe and Imagio Duplex probe in ultrasound only and OA modes Imagio: Imagio - both ultrasound probe and Duplex OA probe
Number of Participants With Imagio Image Sets Collected	38 Participants

PRIMARY outcome

Timeframe: Baseline

Provide breast pathology results per subject (except BI-RADS 1, 2 and 3 (as applicable)) if subject's study mass is biopsied

Outcome measures

Outcome measures
Measure	Imagio n=38 Participants Imagio Grayscale only probe and Imagio Duplex probe in ultrasound only and OA modes Imagio: Imagio - both ultrasound probe and Duplex OA probe
Number of Subjects With Completed Pathology Results	23 Participants

Adverse Events

Imagio

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Imagio n=38 participants at risk Imagio Grayscale only probe and Imagio Duplex probe in ultrasound only and OA modes Imagio: Imagio - both ultrasound probe and Duplex OA probe
General disorders Medical Device Site Warmth	2.6% 1/38 • Number of events 1 • Adverse events were recorded from the time the patient entered the Imagio imaging room until they departed from the facility the same day. There were no follow-up exams for this study (up to 3 hours).

Additional Information

Shaan Schaeffer

Seno Medical, Inc.

Phone: 6106983259

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee INSTITUTION/INVESTIGATOR will provide such proposed publications/presentations, to SPONSOR for review, at least thirty (30) days prior to submission for publication or of public disclosure. SPONSOR will complete its review within thirty (30) days of receipt of the submitted publications/presentations. The INSTITUTION shall consider SPONSOR's suggestions and comments to the manuscript to be published.
Publication restrictions are in place

Restriction type: OTHER