BÜHLMANN fPELA in the Diagnosis of Exocrine Pancreatic Insufficiency

• Sponsor: Bühlmann Laboratories AG (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04548778
• Collaborator: (none)
• Enrollment: 190
• Location: 1
• Anticipated Duration (Months): 25
• Patients Per Site Per Month: 7.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Exocrine Pancreatic Insufficiency	Diagnostic Test: BÜHLMANN fPELA assay

Study Design

• Study Type: Observational
• Anticipated Enrollment: 190 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Clinical Evaluation of BÜHLMANN Fecal Pancreatic Elastase (fPELA) Tests in the Diagnosis of Exocrine Pancreatic Insufficiency (PEI)
• Actual Study Start Date: Nov 1, 2020
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
exocrine pancreatic insufficiency (PEI) Established diagnosis of PEI based on a routine clinical diagnostic work-up including a treat-to-diagnose approach using Pancreatic Enzyme Replacement Therapy (PERT).	Diagnostic Test: BÜHLMANN fPELA assay; BÜHLMANN fPELA assays are immunoassays for the quantitative determination of fecal pancreatic elastase in human stool samples.
no exocrine pancreatic insufficiency (no PEI) No evidence of PEI according to routine clinical diagnostic work-up including a treat-to-diagnose approach using Pancreatic Enzyme Replacement Therapy (PERT).	Diagnostic Test: BÜHLMANN fPELA assay; BÜHLMANN fPELA assays are immunoassays for the quantitative determination of fecal pancreatic elastase in human stool samples.

Outcome Measures

Primary Outcome Measures

1. Clinical Performance of BÜHLMANN fPELA assays in the diagnosis of PEI [December 2021]

   Diagnostic sensitivity and specificity of BÜHLMANN fPELA assays

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinikum Halle (Saale)	Halle (Saale)		Germany	06120

Sponsors and Collaborators

• Bühlmann Laboratories AG

Investigators

• Principal Investigator: Jonas Rosendahl, MD, Universitätsklinikum der Martin-Luther-Universität Halle-Wittenberg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bühlmann Laboratories AG
• ClinicalTrials.gov Identifier: NCT04548778
• Other Study ID Numbers: fPELA_ClinPerform2020
• First Posted: Sep 16, 2020
• Last Update Posted: Mar 15, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Exocrine Pancreatic Insufficiency

Study Results

No Results Posted as of Mar 15, 2022