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BÜHLMANN FPELA in the Diagnosis of Exocrine Pancreatic Insufficiency

NCT04548778 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 201

Last updated 2024-12-16

No results posted yet for this study

Summary

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.

Conditions

  • Exocrine Pancreatic Insufficiency

Interventions

DIAGNOSTIC_TEST

BÜHLMANN fPELA assay

BÜHLMANN fPELA assays are immunoassays for the quantitative determination of fecal pancreatic elastase in human stool samples.

Sponsors & Collaborators

  • Bühlmann Laboratories AG

    lead INDUSTRY

Principal Investigators

  • Jonas Rosendahl, MD · Universitätsklinikum der Martin-Luther-Universität Halle-Wittenberg

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2024-09-21
Completion
2024-09-21

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04548778 on ClinicalTrials.gov