Beta Study to Evaluate Functionality and Equivalence of MPBA (Multi Purpose Breath Analyzer-new Generation Exalenz Breath Analyzer) Compared to Currently Approved BreathID System in Assessment of Liver Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- DOB Peak
研究概览
简要总结
The aim of the study is to confirm that the new generation state of the art breath analyzer gives equivalent results to the previous model of the Exalenz breath analyzer.
详细描述
Healthy and chronic liver disease subjects of all grades will be tested to see that the two devices give equivalent results in both devices. Subjects will be connected to both devices at the same time and will be tested for one hour.
The breath test includes automatic baseline breath collection, 13C-Methacetin ingestion in solution and breath collection post ingestion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 是
入选标准
- •Over 18 years of age
- •Ability and willingness to sign the Informed Consent Form
- •For patient group:
- •a. Known chronic liver disease (based on medical history)
- •For healthy volunteers:
- •3.b. No known liver disease (based on medical history)
排除标准
- •Gastric bypass surgery or extensive small bowel resection
- •Total parenteral nutrition
- •Pregnant or breast feeding
- •Allergy to acetaminophen and/or other related medications.
- •Documented drug-related concurrent hepatotoxicity or drug-related silent steatosis or drug-related fibrosis (e.g. amiodarone, methotrexate and tamoxifen).
- •Uncontrolled malabsorption or diarrhea
- •Placement of a transjugular intrahepatic portosystemic shunt (TIPS)
- •Subject should not have taken any of the following for at least 48 hours prior to the breath test: Acyclovir, allopurinol, carbamazepine, cimetidine, ciprofloxacin, daidzein, (herbal) disulfiram, echinacea, enoxacin, famotidine, fluvoxamine, methoxsalen, mexiletine, montelukast, norfloxacin, phenylpropanolamine, phenytoin, propafenone, rifampin, terbinafine, ticlopidine, thiabendazole, verapamil, zileuton or oral contraceptives or any medication that might interfere with Methacetin metabolism or might affect CYP 1A2
- •Subject should not have taken amiodarone within the last 30 days prior to the breath test
研究组 & 干预措施
HV with MPBA and BID
Healthy volunteers (HV) with no known liver disease will undergo the breath test with the MPBA and the BID before and after substrate ingestion.
干预措施: BreathID (Device)
CLD with MPBA and BID
Chronic Liver Disease (CLD) patients of all degrees will be offered to be tested on the MPBA (multi purpose breath analyzer) and BID (BreathID) on a walk- in basis with , proving they meet inclusion/exclusion criteria.
干预措施: MPBA System (Device)
CLD with MPBA and BID
Chronic Liver Disease (CLD) patients of all degrees will be offered to be tested on the MPBA (multi purpose breath analyzer) and BID (BreathID) on a walk- in basis with , proving they meet inclusion/exclusion criteria.
干预措施: BreathID (Device)
HV with MPBA and BID
Healthy volunteers (HV) with no known liver disease will undergo the breath test with the MPBA and the BID before and after substrate ingestion.
干预措施: MPBA System (Device)
结局指标
主要结局
DOB Peak
时间窗: One hour
The DOB (Delta over Baseline) is measured before and after ingestion of challenging test substrate: 13C- Methacetin. The peak of the DOB is indicative of liver health.
次要结局
- Number of subjects with adverse events related to breath test substrate(48 hours)