Clinical Evaluation of Opto-Acoustic Image Quality With the Gen 2 Imagio System
Completed · Not applicable
Conditions studied: Breast Cancer Stage
In brief
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).
Key facts
- Study ID
- NCT05022602
- Run by
- Seno Medical Instruments Inc.
- People needed
- 38
- Starts
- 2021-08-19
- Expected to finish
- 2022-02-17
- Last updated by the study team
- 2023-03-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- UT Health — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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