An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea Breath Test to predicate devices on the market.
An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea Breath Test to predicate devices on the market. Predicate devices include: Histology, Culture, RUT, and other 13C Breath Tests.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
415
Breath will be analyzed for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.
Biopsy specimen fixed with 10% buffered formalin were cut into 4mm sections, stained with Giemsa stain, and examined by experienced pathologist
Biopsy specimen obtained and placed onto Rapid Urease Test
American Gastroenterology and Hepatology
Clearwater, Florida, United States
South Lake Gastrenology
Clermont, Florida, United States
Florida Center for Gastroenterology
Largo, Florida, United States
Habana Medical Center
Tampa, Florida, United States
Overall Percent Agreement
The primary study endpoint is the performance measure in initial diagnosis (histology, RUT, culture) compared to the PyloPlus 13C UBT System Primary outcome of this study is to provide overall percent agreement in initial diagnosis with the PyloPlus 13C UBT System in comparison to other known diagnostic tools (histology, RUT, culture).
Time frame: 2 Visits
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Biopsy specimen obtained and sent to lab for culture analysis
Whitaker, Weintraub & Grizzard
Tampa, Florida, United States
Bay Area Gastroenterology Associates
Trinity, Florida, United States