The primary objective is to obtain stool samples from subjects diagnosed with , and displaying signs and/or symptoms of IBD and/or IBS will be evaluated in this study. Eligible subjects require a diagnostic colonoscopy with possible biopsy and clinical evaluation.
Stools will be collected and tested, at a later date, in a clinical performance study with an investigational Calprotectin assay. This study will be coordinated by the Sponsor.
Study Type
OBSERVATIONAL
Enrollment
240
Stool sample collected by a subject who have been diagnosed with IBD, IBS or other GI disorder. The stool sample is tested in a laboratory where fecal calprotectin levels are quantified.
One (1) Location in Dothan, Alabama
Dothan, Alabama, United States
One (1) Facility in Arkansas
Little Rock, Arkansas, United States
One (1) Location in California
Mission Hills, California, United States
One (1) Location in Colorado Springs, Colorado
Colorado Springs, Colorado, United States
One (1) Location in Lauderdale Lakes, FL
Lauderdale Lakes, Florida, United States
One (1) Location in Maitland, FL
Maitland, Florida, United States
One (1) Location in Miami, Florida
Miami, Florida, United States
One (1) Location in St. Augustine, FL
Saint Augustine, Florida, United States
One (1) Location in Atlanta, GA
Atlanta, Georgia, United States
One (1) Location in Minneapolis, MN
Minneapolis, Minnesota, United States
...and 3 more locations
Calprotectin Stool Collection
In vitro diagnostic (IVD) device performance
Time frame: Through Study Completion, an average of 1 year
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