Ignite Creation Date:
2024-05-06 @ 12:46 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01650831
Status:
COMPLETED
Last Update Posted:
2022-12-20
First Post:
2012-07-24
Brief Title:
Show Equivalence of the Modified BreathID Compared to Currently Approved BreathID in HPylori Detection
Sponsor:
Meridian Bioscience Inc
Organization:
Meridian Bioscience Inc
Study Overview
Official Title:
Clinical Study to Evaluate the Equivalence of the Modified BreathID Compared to Currently Approved BreathID System in Detection of HPylori Infection
Status:
COMPLETED
Status Verified Date:
2022-12
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 equivalence of a new generation breath analyzer Modified BreathID in its ability to detect H pylori compared to the currently approved BreathID System
Detailed Description:
The ¹³C-Urea Breath Test UBT is a non-invasive test for detecting the presence of Helicobacter pylori H pylori infection by the organisms urease activity In the presence of H pylori the ingestion of urea labeled with the non-radioactive isotope 13C results in production of labeled 13CO2 which can be quantified in expired breath Each test is performed using a test kit consisting of a 13C-urea tablet and citrica powder to be dissolved in tap water 13C-urea solution Before and after ingestion of the 13C-urea solution samples of exhaled breath can be collected using a nasal cannula for real-time analysis and comparison to baseline concentrations The patients exhaled breath is analyzed and the ratio between 13CO2 and 12CO2 is computed The patient is considered H pylori positive when the difference between the ratios exceeds a predefined threshold 5 delta over baseline DOB The current device marketed by Exalenz is large and costly Exalenz has built a smaller cheaper and more reliable new generation device for this application Equivalence is being demonstrated in this study
Study Oversight
Has Oversight DMC:
None
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?:
None