Exalenz Lab Mode System Compared to Biopsy for H.Pylori Detection

Helicobacter Pylori Infection Clinical Trial

Official title:

Clinical Validation Study to Evaluate Presence of H. Pylori With 13C-Urea Breath Test Using the BreathID® Hp Lab System Compared to Biopsy Results

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02528721
• Other study ID #: DM2-HP-0715
• Status: Completed
• Phase: Phase 3
• Start date: October 2015
• Est. completion date: July 2016

Study information

• Verified date: December 2022
• Source: Meridian Bioscience, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Exalenz Dual Mode BreathID® Hp System comprised of IDkit: Hp™ TWO and the Dual Mode BreathID® Hp test device will be used to perform a urea breath test in the initial diagnosis and post treatment monitoring of H.pylori infection in adult patients and its results will be compared to biopsy results.

Description:

Patients undergoing esophagogastroduodenoscopy (EGD) for initial diagnosis of H.pylori infection or post therapy confirmation of eradication will be eligible to participate in the trial. Two sets of biopsies will be taken: one set for histological analysis and one set for rapid urease test (RUT) analysis. The two results will be used as a gold standard composite score in determining the presence of H.pylori bacteria in the stomach. The Urea Breath Test (UBT) using the Exalenz Dual Mode BreathID Hp System will also be performed within a week of the biopsy. The outcome of the UBT will be compared to composite score of the biopsy and the accuracy of the UBT will be evaluated. The UBT will be performed using breath collection bags, where the subject will be asked to breathe into the bags before and after ingestion of the 13C-labelled urea.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be at least 18 years of age.

• Have the ability and willingness to sign the Informed Consent Form.

• Present with clinical indication of H. pylori and a candidate for upper endoscopy

For Initial Diagnosis arm:

• Symptomatic patients naïve to H.pylori treatment in the past 18 months

For Post-Therapy arm:

• Documented biopsy with positive outcome prior to eradication therapy (including method of determination)

• Documented eradication therapy within the past 6 months and completed at least 6 weeks prior to UBT

Exclusion Criteria:

• Participation in other interventional trials.

• Antibiotics and/or Bismuth preparations within four (4) weeks prior to breath test.

• PPI or H2 blockers within two (2) weeks prior to breath test.

• Pregnant or breastfeeding women.

• Allergy to test substrates.

• Patient did not fast for the hour prior to the UBT

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Device:
• Dual Mode BreathID Hp System
The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device

Locations

Country	Name	City	State
Israel	Barzilai Medical center	Ashkelon
Israel	Assaf Harofe Medical Center	Tzrifin
United States	Metropolitan Gastro Group	Chevy Chase	Maryland
United States	Palmetto Research	Hialeah	Florida
United States	Hope Clinical Research	Kissimmee	Florida
United States	Innovative Clincal Research	Lafayette	Colorado
United States	Digestive Disease Care	New Hyde Park	New York
United States	Innovative Clinical Research	Rapid City	South Dakota
United States	Digestive Disease Center of South Texas, P.L.L.C	San Antonio	Texas
United States	Del Sol Research Management	Tucson	Arizona
United States	Ventura Clinical Trials	Ventura	California
United States	Great Lakes Medical Research	Willoughby	Ohio
United States	Gasrtrenetrology Associates of Western Michigan, West Michigan Clinical Research Center	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Meridian Bioscience, Inc.

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity is Described as the Accuracy of the Breath Test in Detecting H.Pylori Infection Compared to Biopsy	Sensitivity of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result	9 months
Primary	Specificity as Described as the Accuracy of the Breath Test in Detecting Absence of H.Pylori Infection Compared to Biopsy	Specificity of urea breath test with Dual Mode Breath Hp System in accurately detecting lack of presence of H.pylori infection as compared to composite biopsy result	9 months
Primary	Overall Agreement in Determining Presence or Absence of H.Pylori Infection Compared to Biopsy	Overall Agreement of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result	9 months