NCT05022602已完成不适用
Clinical Evaluation of Opto-Acoustic Image Quality With the Gen 2 Imagio System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Number of Subjects With Completed Pathology Results
研究概览
简要总结
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).
详细描述
- 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))
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Imagio
Experimental
Imagio Grayscale only probe and Imagio Duplex probe in ultrasound only and OA modes
干预措施: Imagio (Device)
结局指标
主要结局
Number of Subjects With Completed Pathology Results
时间窗: Baseline
Provide breast pathology results per subject (except BI-RADS 1, 2 and 3 (as applicable)) if subject's study mass is biopsied
Number of Participants With Imagio Image Sets Collected
时间窗: 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.
次要结局
未报告次要终点
研究者
研究点 (1)
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