Trials / Completed
CompletedNCT04548778
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)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 201 (actual)
- Sponsor
- Bühlmann Laboratories AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | BÜHLMANN fPELA assay | BÜHLMANN fPELA assays are immunoassays for the quantitative determination of fecal pancreatic elastase in human stool samples. |
Timeline
- Start date
- 2020-11-01
- Primary completion
- 2024-09-21
- Completion
- 2024-09-21
- First posted
- 2020-09-16
- Last updated
- 2024-12-16
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04548778. Inclusion in this directory is not an endorsement.