Clinical Validation Study to Evaluate Presence of H. Pylori With 13C-Urea Breath Test Using the BreathID® Hp Lab System Compared to Biopsy Results
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 282
- 试验地点
- 26
- 主要终点
- Specificity as Described as the Accuracy of the Breath Test in Detecting Absence of H.Pylori Infection Compared to Biopsy
研究概览
简要总结
The Exalenz Dual Mode BreathID® Hp System comprised of IDkit: Hp™ TWO and the Dual Mode BreathID® Hp test device will be used to perform a urea breath test in the initial diagnosis and post treatment monitoring of H.pylori infection in adult patients and its results will be compared to biopsy results.
详细描述
Patients undergoing esophagogastroduodenoscopy (EGD) for initial diagnosis of H.pylori infection or post therapy confirmation of eradication will be eligible to participate in the trial. Two sets of biopsies will be taken: one set for histological analysis and one set for rapid urease test (RUT) analysis. The two results will be used as a gold standard composite score in determining the presence of H.pylori bacteria in the stomach. The Urea Breath Test (UBT) using the Exalenz Dual Mode BreathID Hp System will also be performed within a week of the biopsy. The outcome of the UBT will be compared to composite score of the biopsy and the accuracy of the UBT will be evaluated. The UBT will be performed using breath collection bags, where the subject will be asked to breathe into the bags before and after ingestion of the 13C-labelled urea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Be at least 18 years of age.
- •Have the ability and willingness to sign the Informed Consent Form.
- •Present with clinical indication of H. pylori and a candidate for upper endoscopy
- •For Initial Diagnosis arm:
- •Symptomatic patients naïve to H.pylori treatment in the past 18 months
- •For Post-Therapy arm:
- •Documented biopsy with positive outcome prior to eradication therapy (including method of determination)
- •Documented eradication therapy within the past 6 months and completed at least 6 weeks prior to UBT
排除标准
- •Participation in other interventional trials.
- •Antibiotics and/or Bismuth preparations within four (4) weeks prior to breath test.
- •PPI or H2 blockers within two (2) weeks prior to breath test.
- •Pregnant or breastfeeding women.
- •Allergy to test substrates.
- •Patient did not fast for the hour prior to the UBT
结局指标
主要结局
Specificity as Described as the Accuracy of the Breath Test in Detecting Absence of H.Pylori Infection Compared to Biopsy
时间窗: 9 months
Specificity of urea breath test with Dual Mode Breath Hp System in accurately detecting lack of presence of H.pylori infection as compared to composite biopsy result
Overall Agreement in Determining Presence or Absence of H.Pylori Infection Compared to Biopsy
时间窗: 9 months
Overall Agreement of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result
Sensitivity is Described as the Accuracy of the Breath Test in Detecting H.Pylori Infection Compared to Biopsy
时间窗: 9 months
Sensitivity of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result
次要结局
未报告次要终点