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NCT04548778 Clinical Trial

BÜHLMANN fPELA in the Diagnosis of Exocrine Pancreatic Insufficiency

Exocrine Pancreatic Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04548778
Other study ID # fPELA_ClinPerform2020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2020
Est. completion date December 2023

Study information
Verified date March 2023
Source Bühlmann Laboratories AG
Contact Stefan Neu, PhD
Phone + 41 61 487 12 12
Email sn@buhlmannlabs.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 190
Est. completion date December 2023
Est. primary completion date August 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Exocrine Pancreatic Insufficiency

Intervention

Diagnostic Test:
• BÜHLMANN fPELA assay
BÜHLMANN fPELA assays are immunoassays for the quantitative determination of fecal pancreatic elastase in human stool samples.

Locations
Country Name City State
Germany Universitätsklinikum Halle (Saale) Halle (Saale)

Sponsors (1)
Lead Sponsor Collaborator
Bühlmann Laboratories AG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical Performance of BÜHLMANN fPELA assays in the diagnosis of PEI Diagnostic sensitivity and specificity of BÜHLMANN fPELA assays December 2021
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