Clinical Validation Study to Evaluate Presence of H. Pylori With 13C-Urea Breath Test Using the Dual Mode BreathID® Hp System Compared to Congruent Biopsy Results
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 193
- 试验地点
- 9
- 主要终点
- overall percent agreement
研究概览
简要总结
A new method of breath collection for testing for Helicobacter Pylori infection has been developed by Exalenz. In this study, it will be compared to the gold standard- endoscopy results to prove its accuracy.
详细描述
This study will validate a breath collection method by comparing a newly developed breath test kit, IDkit:Hp™ TWO using breath collection bags, to congruent biopsy results (a composite reference standard by analyzing specimens with microbial culture, histological examination and rapid urease test- RUT) in detecting H.Pylori
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
- •Present with clinical indication of H. pylori and candidate for upper endoscopy
- •Have the ability and willingness to sign the Informed Consent Form for initial diagnosis cohort
- •Naive to treatment in the past 18 months
- •No known H.pylori status (no conclusive test results within last 6 months)
排除标准
- •Participation in other interventional trials
- •Antibiotics and/or Bismuth preparations within four (4) weeks prior to breath test
- •PPI (proton pump inhibitors) or H2 blockers within two (2) weeks prior to breath test
- •Pregnant or breastfeeding women
- •Allergy to test substrates
研究组 & 干预措施
Initial Diagnosis Cohort
Subjects with clinical indication of H.pylori infection will undergo breath test compared to routine clinical standard of care- endoscopy
干预措施: Breath Test Collection bags (Other)
结局指标
主要结局
overall percent agreement
时间窗: 21 days
The primary study endpoint is the performance measure (overall percent agreement) in initial diagnosis (presence/ absence of H.pylori) between biopsy results and bag mode breath test.
次要结局
- overall percent agreement(21 days)