NCT01650831

Show Equivalence of the Modified BreathID Compared to Currently Approved BreathID in H.Pylori Detection

Clinical Study to Evaluate the Equivalence of the Modified BreathID Compared to Currently Approved BreathID System in Detection of H.Pylori Infection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Meridian Bioscience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 organism's 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 patient's 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.

Conditions

• Suspicion of Being Infected With H.Pylori

Interventions

Type	Name	Description
DEVICE	Modified BreathID	A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula

Timeline

• Start date: 2012-10-01
• Primary completion: 2012-11-01
• Completion: 2013-01-01
• First posted: 2012-07-26
• Last updated: 2022-12-20
• Results posted: 2013-09-02

Locations

1 site across 1 country: United States