Pivotal Study to Evaluate the Efficacy and Safety of the BreathID® System for Detection of Cirrhosis Using the ¹³C-methacetin Breath Test(MBT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 414
- 试验地点
- 20
- 主要终点
- Number of Subjects With Likelihood of Cirrhosis Based on "Hepatic Impairment Score" (HIS)
研究概览
简要总结
This trial is a pivotal trial to validate the use of a 13 C labeled substrate called methacetin and the BreathID automatic breath testing system, for determination of cirrhosis in patients with chronic liver disease.
详细描述
Patients with chronic liver disease who have a recent biopsy will be offered a breath test. Correlation will be shown between histology and breath test in determining cirrhosis.
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
- Single (Investigator)
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
- •Age >18 with chronic liver disease
排除标准
- •Patients that are taking hepatotoxin drug.
- •Patient with severe congestive heart failure
- •Patient with severe pulmonary hypertension
- •Patient with uncontrolled diabetes mellitus
- •Patient with previous surgical bypass surgery for morbid obesity
- •Patient with extensive small bowel resection
- •Patient currently receiving total parenteral nutrition
- •Patient is a recipients of any organ transplant
- •Patients that received any anti-viral treatment within the past year
- •Women who are pregnant
- •Patient allergic to acetaminophen (such as Tylenol or any other related medications)
- •Patient with history of chronic obstructive pulmonary disease or symptomatic bronchial asthma
- •Patients unable to sign informed consent
- •Patients that based on the opinion of the investigator should not be enrolled into this study
- •Patients that are participating in other clinical trials evaluating experimental treatments or procedures
结局指标
主要结局
Number of Subjects With Likelihood of Cirrhosis Based on "Hepatic Impairment Score" (HIS)
时间窗: Study day 1 after a 1 hour test
"Hepatic Impairment Score" (HIS) is a score based on breath test parameters and demographic parameters of the subject being tested. A HIS value greater than 0.14 would mean that the subject is likely to be cirrhotic (based on biopsy result as the gold standard). The HIS is a probability score,i.e. ranges from 0 to 1, where 0 would mean the lowest probability of having liver cirrhosis and 1 would be the highest probability of having liver cirrhosis. This would be compared to the actual biopsy result of cirrhosis detection as the gold standard.
次要结局
- AUC of ROC (Area Under Receiver Operating Characteristic Curve)(At study day 1 after 1 hour test)