NCT04548778已完成不适用
Clinical Evaluation of BÜHLMANN Fecal Pancreatic Elastase (fPELA) Tests in the Diagnosis of Exocrine Pancreatic Insufficiency (PEI)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Clinical Performance of BÜHLMANN fPELA assays in the diagnosis of PEI
研究概览
简要总结
The study shall determine the clinical performance of the BÜHLMANN fecal pancreatic elastase (fPELA) assays in the diagnosis of exocrine pancreatic insufficiency (PEI).
This is a observational and cross-sectional performance study. Specimens and clinical data are collected by a single study site.
Included are subjects for which pancreatic elastase testing was indicated due to a suspected exocrine pancreatic insufficiency and which were at least 18 years of age. Subjects which suffered from diarrhea (stool water content ≥ 75%) at the time of sample collection are excluded from the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •suspected exocrine pancreatic insufficiency
- •at least 18 years of age.
排除标准
- •diarrhea (stool water content ≥ 75%) at the time of sample collection
结局指标
主要结局
Clinical Performance of BÜHLMANN fPELA assays in the diagnosis of PEI
时间窗: December 2021
Diagnostic sensitivity and specificity of BÜHLMANN fPELA assays
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
PE-1 in the Diagnosis of Pancreatic Exocrine InsufficiencyPancreatic Exocrine InsufficiencyNCT05791110Changhai Hospital1,053
已完成
不适用
BÜHLMANN fCAL™ ELISA - Aid in Differentiation of IBD From IBSIrritable Bowel SyndromeInflammatory Bowel DiseaseNCT02351635Bühlmann Laboratories AG478
已完成
不适用
Evaluation of Pancreatic Pseudocyst Drainage With a Metal StentPancreatic PseudocystsNCT01239056University of Florida22
终止
4 期
Creon Use in Coeliac Patients With Low Faecal Pancreatic ElastasePatients With Coeliac Disease and Chronic Diarrhoea (>3 Loose/ Liquid Motions a Day for More Than 4 Weeks)Patients With Pancreatic Exocrine InsufficiencyNCT01865695Sheffield Teaching Hospitals NHS Foundation Trust2
已完成
不适用
Evaluation of change in flow of bile, pancreatic juice and lymph under secretion stimulation with non-contrast MR imaging using Time SLIPmalabsorption syndromeJPRN-UMIN000024819Kawasaki Medical School100