NCT04134520招募中不适用
PL-210: Establish ProLung Test Measurement Collection Protocol for Future Studies.
Fresh Medical Laboratories4 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年2月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Establish the ProLung Test measurement collection protocol for future studies.
研究概览
简要总结
The purpose of this Study is to identify and test different data collection methods to determine which approaches improve the ProLung Testing procedure. Once this Study is complete, the Sponsor plans to evaluate these improvements in future follow up Validation studies that will assess device accuracy using the new measurement collection methods.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •7 2.0 Study Objectives 2.1 Objectives and Aims The purpose of this Study is to identify and test different data collection methods to determine which approaches improve the ProLung Testing procedure and identify approaches that may be useful in evaluating other cancers in addition to lung cancer. Once this Study is complete, the Sponsor plans to evaluate these improvements in future follow up cancer validation studies that will assess device accuracy using the new measurement collection methods.
- •The Specific Aim of this study:
- •Establish the ProLung Test measurement collection protocol for future studies.
- •Assess the safety and tolerability of the ProLung Test procedures. 3.0 Study Design This Study Non-Interventional Observational Multi-Site Study in which the ProLung Test does not affect, influence or alter the subject's normal standard of care. The Study will collect data from multiple sites (1- 15). The Study will enroll a minimum of 100 and a maximum 500 subjects. Each subject will receive one or multiple measurement sessions on separate days. 3.1 Safety and Tolerability Information collected about adverse events and tolerability will be analyzed as described in sections 5.8 and 6.0 (Additional Data Collection and Adverse Events). 3.2 Monitoring The study Sponsor will provide monitors to monitor Protocol compliance and provide guidance pertaining to the management of the Study. 4.0 Subject Selection and Participation 4.1 Inclusion Criteria
- •Subjects who meet all of the following criteria may be enrolled in this Study:
- •Subject is male or female, age 18 or older.
- •Subjects eligible for enrollment in one of three arms as described herein Arm 1: Generally healthy subjects with no known cancer disorder Arm 2: Subjects with a pathological diagnosis of cancer that have not yet received treatment for cancer Arm 3: Subjects with a finding that is suspicious for cancer and have not been pathologically confirmed for cancer and have not yet received treatment for cancer Arm 4: Subjects with a cancer finding that has been pathologically confirmed as benign
- •Subject is capable of understanding and agreeing to fulfill the requirements of this Protocol.
- •Subject has signed the IRB/IEC approved Informed Consent Form ("ICF").
排除标准
- •The following criteria will disqualify a subject from enrollment into this Study:
- •Subject has an implanted electronic device in the chest.
- •Subject presents with an anomalous physical or anatomical condition that precludes ProLung Test measurement.
- •Subject will have undergone unusually strenuous exercise within 24 hours.
- •Subject who has significant systemic diseases such as uncontrolled diabetes, advanced heart failure, or a recent myocardial infarction, or other medical condition such as severe morbid obesity that in the judgment of the Principal Investigator would make him/her unsuitable for the Study.
结局指标
主要结局
Establish the ProLung Test measurement collection protocol for future studies.
时间窗: 1 day
The study will evaluate several data collection methodologies including the China CFDA Study method which utilizes diaphoretic electrodes as the reference electrode at measurement point locations and other methods using brass reference electrode at point locations. In addition, the benefits of obtaining multiple repeat measurements will be evaluated.
次要结局
- Assess the safety and tolerability of the ProLung Test procedures(1 day)
研究者
研究点 (4)
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