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

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ClinicalTrials.gov Identifier: NCT02528721
Recruitment Status : Completed
First Posted : August 19, 2015
Results First Posted : March 3, 2017
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Exalenz Bioscience LTD.

Brief 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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Device: Dual Mode BreathID Hp System Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 282 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
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
Study Start Date : October 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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




Primary Outcome Measures :
  1. Sensitivity is Described as the Accuracy of the Breath Test in Detecting H.Pylori Infection Compared to Biopsy [ Time Frame: 9 months ]
    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

  2. Specificity as Described as the Accuracy of the Breath Test in Detecting Absence of H.Pylori Infection Compared to Biopsy [ Time Frame: 9 months ]
    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

  3. Overall Agreement in Determining Presence or Absence of H.Pylori Infection Compared to Biopsy [ Time Frame: 9 months ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02528721


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

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Responsible Party: Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier: NCT02528721     History of Changes
Other Study ID Numbers: DM2-HP-0715
First Posted: August 19, 2015    Key Record Dates
Results First Posted: March 3, 2017
Last Update Posted: March 3, 2017
Last Verified: November 2016

Additional relevant MeSH terms:
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Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections