Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04548778
Status:
RECRUITING
Last Update Posted:
2023-04-18
First Post:
2020-09-08
Brief Title:
BÜHLMANN fPELA in the Diagnosis of Exocrine Pancreatic Insufficiency
Sponsor:
Bühlmann Laboratories AG
Organization:
Bühlmann Laboratories AG
Study Overview
Official Title:
Clinical Evaluation of BÜHLMANN Fecal Pancreatic Elastase fPELA Tests in the Diagnosis of Exocrine Pancreatic Insufficiency PEI
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None