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

Sponsor

Seno Medical Instruments Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT05022602

Collaborator

American College of Radiology (Other)

Enrollment

Location

Arm

Actual Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Stage	Device: Imagio	N/A

Detailed Description

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.
Provide breast and lymph node pathology results (except BI-RADS 1, 2 and 3 (as applicable))

Study Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Aug 19, 2021

Actual Primary Completion Date :

Feb 17, 2022

Actual Study Completion Date :

Feb 17, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Imagio Imagio Grayscale only probe and Imagio Duplex probe in ultrasound only and OA modes	Device: Imagio Imagio - both ultrasound probe and Duplex OA probe

Arm

Intervention/Treatment

Experimental: Imagio

Imagio Grayscale only probe and Imagio Duplex probe in ultrasound only and OA modes

Device: Imagio

Imagio - both ultrasound probe and Duplex OA probe

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Has a signed and dated informed consent, prior to initiation of any study-related activities.
Is at least 18 years of age.
Have been referred for a breast US because of a breast lesion/mass finding via a palpable lump or per standard of care imaging.
Is willing and able to comply with protocol-required scans

Exclusion Criteria:

Is pregnant or lactating.
Has a condition or breast impediment (i.e. insect bites, poison ivy, rash, open wounds, chafing of the skin, scar, tattoos, moles, hematoma, nipple rings, etc.) which could interfere with the intended field of view.
Is experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as some sulfur containing drugs, ampicillin, tetracycline.
Is currently undergoing phototherapy.
Has a history of any photosensitive disease (e.g., porphyria, lupus erythematosus) or undergoing treatment for a photosensitive disease and is experiencing photosensitivity.
Has had an adverse reaction in the past to medical laser procedures, such as laser hair removal or laser tattoo removal.
Has had prior benign excisional breast biopsy on breast of interest within the past 18 months.
Currently has mastitis.
Prisoners

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UT Health	San Antonio	Texas	United States	78229

Sponsors and Collaborators

Seno Medical Instruments Inc.
American College of Radiology

Investigators

Principal Investigator: Pam Otto, MD, UTHSC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seno Medical Instruments Inc.

ClinicalTrials.gov Identifier:

NCT05022602

Other Study ID Numbers:

Gen 2 - 01

First Posted:

Aug 26, 2021

Last Update Posted:

Mar 7, 2022

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Mar 7, 2022