Skip to main content
MedPathMedPath Home
Clinical Trials/NCT04548778
NCT04548778
Completed
Not Applicable

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

Bühlmann Laboratories AG1 site in 1 country201 target enrollmentNovember 1, 2020
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsExocrine Pancreatic Insufficiency

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Exocrine Pancreatic Insufficiency
Sponsor
Bühlmann Laboratories AG
Enrollment
201
Locations
1
Primary Endpoint
Clinical Performance of BÜHLMANN fPELA assays in the diagnosis of PEI
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
November 1, 2020
End Date
September 21, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Clinical Performance of BÜHLMANN fPELA assays in the diagnosis of PEI

Time Frame: December 2021

Diagnostic sensitivity and specificity of BÜHLMANN fPELA assays

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
PE-1 in the Diagnosis of Pancreatic Exocrine InsufficiencyPancreatic Exocrine Insufficiency
NCT05791110Changhai Hospital1,053
Completed
Not Applicable
BÜHLMANN fCAL™ ELISA - Aid in Differentiation of IBD From IBSInflammatory Bowel DiseaseIrritable Bowel Syndrome
NCT02351635Bühlmann Laboratories AG478
Completed
Not Applicable
Evaluation of Pancreatic Pseudocyst Drainage With a Metal StentPancreatic Pseudocysts
NCT01239056University of Florida22
Terminated
Phase 4
Creon Use in Coeliac Patients With Low Faecal Pancreatic ElastasePatients With Coeliac Disease and Chronic Diarrhoea (>3 Loose/ Liquid Motions a Day for More Than 4 Weeks)Patients With Pancreatic Exocrine Insufficiency
NCT01865695Sheffield Teaching Hospitals NHS Foundation Trust2
Completed
Not Applicable
Evaluation of change in flow of bile, pancreatic juice and lymph under secretion stimulation with non-contrast MR imaging using Time SLIPmalabsorption syndrome
JPRN-UMIN000024819Kawasaki Medical School100