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

Launched by SENO MEDICAL INSTRUMENTS INC. · Aug 20, 2021

Keywords

ClinConnect Summary

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))

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Has a signed and dated informed consent, prior to initiation of any study-related activities.
• • 2. Is at least 18 years of age.
• • 3. Have been referred for a breast US because of a breast lesion/mass finding via a palpable lump or per standard of care imaging.
• • 4. Is willing and able to comply with protocol-required scans
• Exclusion Criteria:
• • 1. Is pregnant or lactating.
• • 2. 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.
• • 3. 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.
• • 4. Is currently undergoing phototherapy.
• • 5. Has a history of any photosensitive disease (e.g., porphyria, lupus erythematosus) or undergoing treatment for a photosensitive disease and is experiencing photosensitivity.
• • 6. Has had an adverse reaction in the past to medical laser procedures, such as laser hair removal or laser tattoo removal.
• • 7. Has had prior benign excisional breast biopsy on breast of interest within the past 18 months.
• • 8. Currently has mastitis.
• • 9. Prisoners