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OpenTrials
Completed

NCT Number: NCT04548778

BÜHLMANN FPELA in the Diagnosis of Exocrine Pancreatic Insufficiency

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.

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Key information

Conditions

Exocrine Pancreatic Insufficiency Digestive System Diseases Pancreatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Halle (Saale)

Halle, 06120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • suspected exocrine pancreatic insufficiency
  • at least 18 years of age.

Exclusion criteria

  • diarrhea (stool water content ≥ 75%) at the time of sample collection

Treatment and study plan

BÜHLMANN fPELA assay

Diagnostic Test

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

Primary outcomes

  1. Clinical Performance of BÜHLMANN fPELA assays in the diagnosis of PEI

    Time frame: December 2021

    Diagnostic sensitivity and specificity of BÜHLMANN fPELA assays

Sponsors and collaborators

Lead sponsor

Bühlmann Laboratories AG

Industry

Registry information

Official study title

Clinical Evaluation of BÜHLMANN Fecal Pancreatic Elastase (fPELA) Tests in the Diagnosis of Exocrine Pancreatic Insufficiency (PEI)

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Sep 16, 2020
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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