VIO Imaging for Skin Tissue Assessment (VISTA) - a Prospective, Multicenter Investigation of the VIO Device in Subjects Undergoing Routine Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 3
- 主要终点
- Comparative Reader Percentage Agreement
研究概览
简要总结
To demonstrate the safety and effectiveness of the VIO device in obtaining in vivo images that show tissue features including epidermis, dermis, collagen, blood vessels, and/or pigment.
To demonstrate that the tissue features identified on the images obtained with the VIO device align with the corresponding pathology images procured from the skin biopsy.
To evaluate the ability of blinded readers to correctly identify tissue features on images obtained with the VIO device.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is between 18 and 99 years of age.
- •The subject or Legally Authorized Representative (LAR) is able and willing to provide written informed consent.
- •The subject is planning to undergo a routine skin biopsy.
- •The subject is willing and able to remain still for periods of up to 3 minutes to allow for image capture.
- •The subject or LAR has sufficient mental capacity to understand the informed consent form (ICF) and comply with the protocol requirements.
排除标准
- •The subject has a general health condition or systemic disease that in the opinion of the physician, precludes them from trial participation.
- •The subject has a known allergy or increased skin sensitivity to silicone, adhesives, or glycerin.
- •The subject's lesion targeted for biopsy:
- •Is located on the palms of the hands, soles of the feet, fingernails, or toenails.
- •Has dense hair that will not be removed prior to the skin biopsy.
- •Has clinically significant abraded or ulcerated skin with or without discharge.
- •Is associated with a wound or skin condition that in the opinion of the physician precludes them from participation
- •Is located in mucosal tissue (i.e., oral, nasal, etc.).
- •Is on tattooed skin.
- •Is on a skin formation too tortuous for the investigational device to access (e.g., skin tags.)
- •Is located in the periorbital region or directly on the eyelid.
结局指标
主要结局
Comparative Reader Percentage Agreement
时间窗: 8 months post-enrollment completion
This outcome measured the % agreement and validation of specific tissue features on VIO images in comparison to gold standard pathology images between N=3 Comparative Readers (CRs). "CRs" were study investigators that were selected based on their experience and medical qualifications. 100% agreement and validation between the CRs was required to proceed to the next study phase.
Blinded Reader Percentage Agreement
时间窗: 8 months post-enrollment completion
This outcome measured the % agreement between N=3 Blinded Readers (BRs) of their assessment of VIO images in comparison to the answer key developed from the Comparative Reader validation. "BRs" were study investigators that were selected based on their experience and medical qualifications. \>90% agreement was required to proceed to the next study phase.
Safety / Adverse Events
时间窗: 7 +/- 3 days after VIO imaging
Safety will be assessed as the incidence of all adverse events (analyzed by severity, seriousness, and relationship to the device and procedure) that occur through the 7-day follow-up period.
次要结局
- Inter-Reader Percentage Agreement(8 months post-enrollment completion)
- Evaluation of Secondary Histopathology Characteristics(8 months post-enrollment completion)