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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier:
NCT01650831
First received: July 24, 2012
Last updated: September 1, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Suspicion of Being Infected With H.Pylori
Device: Modified BreathID

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Clinical Study to Evaluate the Equivalence of the Modified BreathID Compared to Currently Approved BreathID System in Detection of H.Pylori Infection

Further study details as provided by Exalenz Bioscience LTD.:

Primary Outcome Measures:
  • Percentage of Patients With Dichotomous (Presence/Absence of H.Pylori) Outcome Agreement in Diagnosis of H. Pylori [ Time Frame: 25 minutes ] [ Designated as safety issue: No ]
    The marketed (cleared) BreathID device and the investigational modified new generation BreathID device will measure simultaneously before (baseline) and after ingestion of substrate. The subject will be connected to both devices. The maximum time of measurement is 25 minutes.


Enrollment: 113
Study Start Date: October 2012
Study Completion Date: January 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clinical Suspicion of Hpylori
All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions
Device: Modified BreathID
A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula
Other Name: BreathID Hp

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be at least 18 years of age
  2. Present with clinical indication of H. pylori
  3. Have the ability and willingness to sign the Informed Consent Form-

Exclusion Criteria:

  1. Current serious disease
  2. Participation in other trials
  3. Antibiotics and/or Bismuth preparations for four (4) weeks prior to test
  4. PPI or H2 blockers for two (2) weeks prior to test
  5. Childbearing or breastfeeding women
  6. Based on opinion of investigator, subject should not be enrolled in this trial
  7. Allergy to citrus juice
  8. Post -eradication therapy for H. pylori
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650831

Locations
United States, New Jersey
Unimed Center
East Brunswick, New Jersey, United States, 08816
Sponsors and Collaborators
Exalenz Bioscience LTD.
Investigators
Principal Investigator: Jenny Liu, MD Unimed Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier: NCT01650831     History of Changes
Other Study ID Numbers: HP-MBI-0212
Study First Received: July 24, 2012
Results First Received: May 28, 2013
Last Updated: September 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Exalenz Bioscience LTD.:
Helicobacter Pylori
13C Urea Breath Test
BreathID

ClinicalTrials.gov processed this record on October 02, 2014