BÜHLMANN fPELA in the Diagnosis of Exocrine Pancreatic Insufficiency

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

Sponsors

Lead Sponsor: Bühlmann Laboratories AG

Source Bühlmann Laboratories AG
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.

Overall Status Not yet recruiting
Start Date October 2020
Completion Date May 2021
Primary Completion Date May 2021
Study Type Observational
Primary Outcome
Measure Time Frame
Clinical Performance of BÜHLMANN fPELA assays in the diagnosis of PEI December 2021
Enrollment 190
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: BÜHLMANN fPELA assay

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

Eligibility

Sampling Method: Non-Probability Sample

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jonas Rosendahl, MD Principal Investigator Universitätsklinikum der Martin-Luther-Universität Halle-Wittenberg
Overall Contact

Last Name: Stefan Neu, PhD

Phone: + 41 61 487 12 12

Email: [email protected]

Location
Facility: Contact: Universitätsklinikum Halle (Saale) Jonas Rosendahl, MD
Location Countries

Germany

Verification Date

September 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: exocrine pancreatic insufficiency (PEI)

Description: Established diagnosis of PEI based on a routine clinical diagnostic work-up including a treat-to-diagnose approach using Pancreatic Enzyme Replacement Therapy (PERT).

Label: no exocrine pancreatic insufficiency (no PEI)

Description: No evidence of PEI according to routine clinical diagnostic work-up including a treat-to-diagnose approach using Pancreatic Enzyme Replacement Therapy (PERT).

Study Design Info

Observational Model: Cohort

Time Perspective: Cross-Sectional

Source: ClinicalTrials.gov