Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04548778
  4. Details
NCT04548778 Clinical Trial

BÜHLMANN fPELA in the Diagnosis of Exocrine Pancreatic Insufficiency

Exocrine Pancreatic Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04548778
Other study ID # fPELA_ClinPerform2020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2020
Est. completion date December 2023

Study information
Verified date March 2023
Source Bühlmann Laboratories AG
Contact Stefan Neu, PhD
Phone + 41 61 487 12 12
Email sn@buhlmannlabs.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 190
Est. completion date December 2023
Est. primary completion date August 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Exocrine Pancreatic Insufficiency

Intervention

Diagnostic Test:
• BÜHLMANN fPELA assay
BÜHLMANN fPELA assays are immunoassays for the quantitative determination of fecal pancreatic elastase in human stool samples.

Locations
Country Name City State
Germany Universitätsklinikum Halle (Saale) Halle (Saale)

Sponsors (1)
Lead Sponsor Collaborator
Bühlmann Laboratories AG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical Performance of BÜHLMANN fPELA assays in the diagnosis of PEI Diagnostic sensitivity and specificity of BÜHLMANN fPELA assays December 2021
See also
  Status Clinical Trial Phase
Completed NCT02823964 - EASY: Extended Access to Sollpura Over Years Phase 4
Completed NCT02563080 - Pancreatic Exocrine Insufficiency in Acute Pancreatitis
Completed NCT01427725 - Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency
Completed NCT01430234 - Enzyme Suppletion in Exocrine Pancreatic Dysfunction Phase 4
Completed NCT05082051 - Oral CDX-7108 in Healthy Adults and EPI Subjects Phase 1
Completed NCT03236038 - Prevalence of Exocrine Pancreatic Insufficiency in Patients With Decompensated Cirrhosis
Completed NCT03407534 - Detection of Exocrine Pancreatic Insufficiency in Patients With Diarrhea and Bloating
Completed NCT02598128 - Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb) N/A
Completed NCT00559364 - Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea Phase 3
Completed NCT00408317 - Safety and Efficacy Study of ULTRASE® MT20 in Participants With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (PI) Phase 3
Completed NCT00449878 - Liprotamase Efficacy Trial in Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency Phase 3
Completed NCT00981214 - Study of Pancreatic Enzyme Product in Pediatric Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency Phase 3
Completed NCT00297167 - Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency Phase 3
Recruiting NCT05480241 - Exocrine Pancreatic Insufficiency After Acute Pancreatitis and Pancreatic Enzyme Replacement Therapy N/A
Recruiting NCT05261997 - Endotherapy for Painless Chronic Pancreatitis N/A
Completed NCT02370537 - A Study to Investigate How Common Pancreatic Exocrine Insufficiency (PEI) is in Patients With Type 2 Diabetes and Also to Investigate the Uptake of a Single Dose of EPANOVA® or OMACOR® in Patients With Different Degrees of PEI Phase 2
Completed NCT00559052 - An Open-Label Study to Evaluate the Intraduodenal Delivery of Enzymes From Administration of VIOKASE16 in Exocrine Pancreatic Insufficiency (EPI) Phase 2
Recruiting NCT04112836 - Pancreatic Cancer Malnutrition and Pancreatic Exocrine Insufficiency in the Course of Chemotherapy in Unresectable Pancreatic Cancer
Completed NCT06278272 - AI Evaluation of Pancreatic Exocrine Insufficiency in CP Patients
Completed NCT02734810 - SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis Phase 3