BÜHLMANN FPELA in the Diagnosis of Exocrine Pancreatic Insufficiency
NCT ID: NCT04548778
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
201 participants
OBSERVATIONAL
2020-11-01
2024-09-21
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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exocrine pancreatic insufficiency (PEI)
Established diagnosis of PEI based on a routine clinical diagnostic work-up including a treat-to-diagnose approach using Pancreatic Enzyme Replacement Therapy (PERT).
BÜHLMANN fPELA assay
BÜHLMANN fPELA assays are immunoassays for the quantitative determination of fecal pancreatic elastase in human stool samples.
no exocrine pancreatic insufficiency (no PEI)
No evidence of PEI according to routine clinical diagnostic work-up including a treat-to-diagnose approach using Pancreatic Enzyme Replacement Therapy (PERT).
BÜHLMANN fPELA assay
BÜHLMANN fPELA assays are immunoassays for the quantitative determination of fecal pancreatic elastase in human stool samples.
Interventions
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BÜHLMANN fPELA assay
BÜHLMANN fPELA assays are immunoassays for the quantitative determination of fecal pancreatic elastase in human stool samples.
Eligibility Criteria
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Inclusion Criteria
* at least 18 years of age.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Bühlmann Laboratories AG
INDUSTRY
Responsible Party
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Principal Investigators
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Jonas Rosendahl, MD
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum der Martin-Luther-Universität Halle-Wittenberg
Locations
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Universitätsklinikum Halle (Saale)
Halle, , Germany
Countries
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Other Identifiers
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fPELA_ClinPerform2020
Identifier Type: -
Identifier Source: org_study_id