Clinical Evaluation of Opto-Acoustic Image Quality With the Gen1B Duplex Probe in Breast Applications

Seno Medical

Status: Suspended

Conditions: Breast Cancer

Treatments: Device: Gen 1; Device: Gen 1B

Study type: Interventional

Funder types: Industry

Identifiers

NCT03845907

GEN1B-01

Details and patient eligibility

About

Comparative Evaluation of Gen1B (OA-16-1S) duplex OA/US probe versus Gen1 (OA-16-1) duplex OA/US probe in Healthy Subjects

Full description

This study performs the first clinical evaluation of the Gen1B (OA-16-1S) duplex OA/US probe. This probe includes design changes to improve reliability and performance compared to the Gen1 (OA-16-1) duplex OA/US probe. The performance of the Gen1 duplex probe is functionally equivalent to the PIONEER duplex probe (OA-15-3), which was used in previous clinical studies for suspicious breast masses.

Enrollment: 4 patients

Sex: Female

Ages: 18+ years old

Volunteers: 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.
• Is willing to undergo an Imagio imaging evaluation and standard Ultrasound Evaluation of the breast and axillary lymph nodes.
• Is willing and able to comply with protocol-required scans.

Exclusion criteria

• Is pregnant or lactating.
• Has a condition or impediment (i.e. insect bites, poison ivy, rash, open wounds, chafing of the skin, scar, tattoos, moles, breast implants within the previous 12 months, etc.) where the duplex probe will come in contact with the subject, 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 sulfa, 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 a history of contact dermatitis induced by gold or chrome metal contact with skin.
• Has an acute or chronic hematoma and/or acute ecchymosis of the breast.
• Has had prior benign excisional breast biopsy within the past 18 months.
• Has nipple rings that cannot be removed or are not removed during Imagio evaluation.
• Currently has mastitis.
• Has focal pain in the breast.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Imagio Gen 1B

Active Comparator group

Description:

Gen 1B duplex probe ultrasound / optoacoustic imaging of the breast and axillary lymph node, with the IMAGIO System and the Gen1B duplex probe

Treatment:

Device: Gen 1

Device: Gen 1B

Imagio Gen 1

Active Comparator group

Description:

Gen 1 duplex probe ultrasound / optoacoustic imaging of the breast and axillary lymph node, with the IMAGIO System

Treatment:

Device: Gen 1

Device: Gen 1B