Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-03 @ 9:06 AM
Study NCT ID:
NCT02351635
Status:
COMPLETED
Last Update Posted:
2019-01-18
First Post:
2015-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BÜHLMANN fCAL™ ELISA - Aid in Differentiation of IBD From IBS
Sponsor:
Bühlmann Laboratories AG
Organization:
Study Overview
Official Title:
Clinical Study of the BÜHLMANN fCAL™ ELISA as an Aid in the Differentiation of Inflammatory Bowel Disease From Irritable Bowel Syndrome
Status:
COMPLETED
Status Verified Date:
2019-01
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 purpose of this study is to confirm the sensitivity and specificity of the BÜHLMANN fCAL™ ELISA as an aid in diagnosis to differentiate between Inflammatory Bowel Disease (IBD; Crohn's Disease (CD), Ulcerative Colitis (UC), or indeterminate colitis) and Irritable Bowel Syndrome (IBS).
To estimate the predictive value of a positive test (positive predictive value (PPV)) and the predictive value of a negative test (Negative Predictive Value (NPV)) using the proposed test outcomes for BÜHLMANN Calprotectin Test results when used in patients referred for diagnostic evaluation with signs and symptoms suggestive of either IBS or IBD.
To confirm the inter-laboratory consistency of test results for the BÜHLMANN fCAL™ ELISA.
To provide exploratory observations of test results in patients between the age of 2 and 21 years.
To provide a sample set from normal subjects with no symptoms or signs of gastrointestinal disease for use in Expected Value Testing.
To estimate the predictive value of a positive test (positive predictive value (PPV)) and the predictive value of a negative test (Negative Predictive Value (NPV)) using the proposed test outcomes for BÜHLMANN Calprotectin Test results when used in patients referred for diagnostic evaluation with signs and symptoms suggestive of either IBS or IBD.
To confirm the inter-laboratory consistency of test results for the BÜHLMANN fCAL™ ELISA.
To provide exploratory observations of test results in patients between the age of 2 and 21 years.
To provide a sample set from normal subjects with no symptoms or signs of gastrointestinal disease for use in Expected Value Testing.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: