An open label, non-randomized study of the PYtest ® Kit (urea[14C] breath test) for the detection of helicobacter pylori
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of PYtest® (urea[14C] breath test) kit in comparison to Rapid urease diagnostic test.
研究概览
简要总结
The purpose of the study is to establish the sensitivity and specificity of the PYtest® (urea[14C] capsule) in comparison to Rapid urease diagnostic test in Indian population.
To evaluate the sensitivity and specificity of PYtest® (urea[14C] breath test) kit for H. pylori in comparison to Rapid urease diagnostic test. Also to evaluate the safety of Urea[14C] capsule of PYtest ® Kit.
Sensitivity, specificity, positive predictive value, and negative predictive value will be determined using a 2x2 table for comparison between breath test and reference methods. The product of positive predictive value and negative predictive value will be used to define the accuracy. One-sided 95% confidence intervals for sensitivity and specificity as well as positive and negative predictive values will be calculated using one sample binomial test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who present with clinical symptoms of H.
- •pylori Have the ability and willingness to sign the Informed Consent Form.
排除标准
- •Patient with current serious underlying disease.
- •Participation in other trials currently.
- •Patients who have been taking or have taken antibiotics and/or bismuth preparations for (4) weeks prior to test.
结局指标
主要结局
Sensitivity and specificity of PYtest® (urea[14C] breath test) kit in comparison to Rapid urease diagnostic test.
时间窗: The diagnostic tests will be performed during Visit 2, which should be scheduled within 3 days of Visit 1 (Screening). | Visit 2 will include the following procedures: | • Endoscopy and Rapid Urease Test | • PYtest® (urea[14C] capsule) administration and Urea breath analysis
次要结局
- To evaluate the safety of Urea[14C] capsule of PYtest ® Kit(The safety will be evaluated during Visit 2, which should be scheduled within 3 days of Visit 1 (Screening), & at the end of the study (follow up period), that is within 3 days of the Visit 2 .)
研究者
Dr Narasimhaiah S
Apollo Hospital