ARJ C13 Urea Breath Test System
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 415
- 试验地点
- 12
- 主要终点
- Overall Percent Agreement
研究概览
简要总结
An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea Breath Test to predicate devices on the market.
详细描述
An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea Breath Test to predicate devices on the market. Predicate devices include: Histology, Culture, RUT, and other 13C Breath Tests.
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
- 否
入选标准
- •Male or female at least 18 years of age at the time of visit
- •Patients who are experiencing the effects of gastritis
- •Written informed consent (and assent when applicable) obtained from subject and ability for subject to comply with the requirements of the study
排除标准
- •Pregnant or lactating women.
- •Study subjects currently taking antibiotics
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
- •Fasting required one hour prior to testing
- •Study subjects shall not consume the following items prior to the test: Mouthwash, Chewing Gum, Carbonated Beverages, Cigarette Smoke, Acetone (to stimulate the effect of ketone production that may result from some diets), Alcohol
研究组 & 干预措施
Indication for H.pylori testing
Walk in basis: Symptomatic patients of H.pylori infection will be enrolled for this study if all acceptance criteria are met. Patients will undergo C13 Urea Breath Test in addition to at least 2 other diagnostic tools from one obtained biopsy as comparison.
干预措施: PyloPlus UBT System (Combination Product)
Indication for H.pylori testing
Walk in basis: Symptomatic patients of H.pylori infection will be enrolled for this study if all acceptance criteria are met. Patients will undergo C13 Urea Breath Test in addition to at least 2 other diagnostic tools from one obtained biopsy as comparison.
干预措施: Histology (Diagnostic Test)
Indication for H.pylori testing
Walk in basis: Symptomatic patients of H.pylori infection will be enrolled for this study if all acceptance criteria are met. Patients will undergo C13 Urea Breath Test in addition to at least 2 other diagnostic tools from one obtained biopsy as comparison.
干预措施: Rapid Urease Test (Diagnostic Test)
Indication for H.pylori testing
Walk in basis: Symptomatic patients of H.pylori infection will be enrolled for this study if all acceptance criteria are met. Patients will undergo C13 Urea Breath Test in addition to at least 2 other diagnostic tools from one obtained biopsy as comparison.
干预措施: H.pylori Culture (Diagnostic Test)
结局指标
主要结局
Overall Percent Agreement
时间窗: 2 Visits
The primary study endpoint is the performance measure in initial diagnosis (histology, RUT, culture) compared to the PyloPlus 13C UBT System Primary outcome of this study is to provide overall percent agreement in initial diagnosis with the PyloPlus 13C UBT System in comparison to other known diagnostic tools (histology, RUT, culture).
次要结局
未报告次要终点