Clinical Evaluation of Opto-Acoustic Image Quality With the Gen1B Duplex Probe in Breast Applications
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Number of Subjects with Treatment-related Events
研究概览
简要总结
Comparative Evaluation of Gen1B (OA-16-1S) duplex OA/US probe versus Gen1 (OA-16-1) duplex OA/US probe in Healthy Subjects
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
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.
- •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.
排除标准
- •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.
结局指标
主要结局
Number of Subjects with Treatment-related Events
时间窗: At end of study, average of six months
Safety of the Gen 1B duplex Optoacoustic (OA)/ Ultrasound (US) probe in breast applications as compared to Gen 1 with respect to treatment-related events
Diagnostic Image Quality of Gen 1B
时间窗: At end of study, average of six months
Independent reader comparison using questionnaire and measurements on artifacts and features of Gen 1 Gen1B probe images for pair wise comparison
次要结局
- Probe performance data comparison across skin types(At end of study, average of six months)
- Image Quality between probes at reduced laser level(At end of study, average of six months)