An observational study in Exocrine Pancreatic Insufficiency, sponsored by Bühlmann Laboratories AG. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by Bühlmann Laboratories AG · Observational
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.
136 studies on the registry are indexed under Exocrine Pancreatic Insufficiency; 26 are open to participants now.
This study's enrollment of 201 is above the median of 120 across 38 observational studies indexed under Exocrine Pancreatic Insufficiency.
Browse Exocrine Pancreatic Insufficiency studies →Bühlmann Laboratories AG is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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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. Following patient groups show an increased risk for developing an exocrine insufficiency: chronic pancreatitis, cystic fibrosis, diabetes, pancreatic resection. Eligible study subjects provide one stool sample which is forwarded to the study site within three days.
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Exclusion Criteria:
Established diagnosis of PEI based on a routine clinical diagnostic work-up including a treat-to-diagnose approach using Pancreatic Enzyme Replacement Therapy (PERT).
Diagnostic Test: BÜHLMANN fPELA assay
No evidence of PEI according to routine clinical diagnostic work-up including a treat-to-diagnose approach using Pancreatic Enzyme Replacement Therapy (PERT).
Diagnostic Test: BÜHLMANN fPELA assay
BÜHLMANN fPELA assays are immunoassays for the quantitative determination of fecal pancreatic elastase in human stool samples.
Clinical Performance of BÜHLMANN fPELA assays in the diagnosis of PEI
Diagnostic sensitivity and specificity of BÜHLMANN fPELA assays
Time frame: December 2021
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Exocrine Pancreatic Insufficiency →
Bühlmann Laboratories AG