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

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

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Device: Dual Mode BreathID Hp System

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 282
• Phase: Phase 3

Contacts and Locations

Study Locations

• Israel
  • Ashkelon, Israel, 7830604
    • Barzilai Medical Center
  • Tzrifin, Israel, 70300
    • Assaf Harofe Medical Center
• United States
  • Arizona
    • Tucson, Arizona, United States, 85710
      • Del Sol Research Management
  • California
    • Ventura, California, United States, 93003
      • Ventura Clinical Trials
  • Colorado
    • Lafayette, Colorado, United States, 80026
      • Innovative Clincal Research
  • Florida
    • Hialeah, Florida, United States, 33016
      • Palmetto Research
    • Kissimmee, Florida, United States, 34741
      • Hope Clinical Research
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Metropolitan Gastro Group
  • Michigan
    • Wyoming, Michigan, United States, 49519
      • Gasrtrenetrology Associates of Western Michigan, West Michigan Clinical Research Center
  • New York
    • New Hyde Park, New York, United States, 11040
      • Digestive Disease Care
  • Ohio
    • Willoughby, Ohio, United States, 44094
      • Great Lakes Medical Research
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Innovative Clinical Research
  • Texas
    • San Antonio, Texas, United States, 78215
      • Digestive Disease Center of South Texas, P.L.L.C

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Initial Diagnosis Subjects; Patients with clinical indication for H.pylori infection	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; Other Names: Hp™ TWO; Dual Mode BreathID® Hp
Experimental: Post Therapy Subjects; Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months	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; Other Names: Hp™ TWO; Dual Mode BreathID® Hp

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Meridian Bioscience, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: August 17, 2015
• First Submitted That Met QC Criteria: August 18, 2015
• First Posted (Estimate): August 19, 2015

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: DM2-HP-0715