Bag Mode BreathID Hp Validation Versus Endoscopy in Detection of Helicobacter Pylori

This study is currently recruiting participants.
Verified March 2014 by Exalenz Bioscience LTD.
Sponsor:
Information provided by (Responsible Party):
Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier:
NCT02010112
First received: December 5, 2013
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

A new method of breath collection for testing for Helicobacter Pylori infection has been developed by Exalenz. In this study, it will be compared to the gold standard- endoscopy results to prove its accuracy.


Condition Intervention Phase
Helicobacter Pylori Infection
Other: Breath Test Collection bags
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Clinical Validation Study to Evaluate Presence of H. Pylori With 13C-Urea Breath Test Using the Dual Mode BreathID® Hp System Compared to Congruent Biopsy Results

Resource links provided by NLM:


Further study details as provided by Exalenz Bioscience LTD.:

Primary Outcome Measures:
  • overall percent agreement [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    The primary study endpoint is the performance measure (overall percent agreement) in initial diagnosis (presence/ absence of H.pylori) between biopsy results and bag mode breath test.


Secondary Outcome Measures:
  • overall percent agreement [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    The performance measure (overall percent agreement) in post-therapy diagnosis (presence/ absence of H.pylori) between the Dual Mode BreathID® Hp System when using only one pair of IDkit:Hp™ TWO breath collection bags measured within 9 days and congruent biopsy results


Estimated Enrollment: 161
Study Start Date: January 2014
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Initial Diagnosis Cohort
Subjects with clinical indication of H.pylori infection will undergo breath test compared to routine clinical standard of care- endoscopy
Other: Breath Test Collection bags
Breath Collection bags will be used to collect breath of subjects before and after ingestion of 13-C breath test substrate
Other Name: IDKit Two

Detailed Description:

This study will validate a breath collection method by comparing a newly developed breath test kit, IDkit:Hp™ TWO using breath collection bags, to congruent biopsy results (a composite reference standard by analyzing specimens with microbial culture, histological examination and rapid urease test- RUT) in detecting H.Pylori

  Eligibility

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

Inclusion Criteria:

  • Present with clinical indication of H. pylori and candidate for upper endoscopy
  • Have the ability and willingness to sign the Informed Consent Form for initial diagnosis cohort
  • Naive to treatment in the past 18 months
  • No known H.pylori status (no conclusive test results within last 6 months)

Exclusion Criteria:

  • Participation in other interventional trials
  • Antibiotics and/or Bismuth preparations within four (4) weeks prior to breath test
  • PPI (proton pump inhibitors) or H2 blockers within two (2) weeks prior to breath test
  • Pregnant or breastfeeding women
  • Allergy to test substrates
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02010112

Contacts
Contact: Avraham Hershkowitz, Msc. +972-546605412 avrahamh@exalenz.com
Contact: Gil Guggenheim, BSc. +972-89737514 gilg@exalenz.com

Locations
United States, Maryland
Digestive Disease Associates, PA Recruiting
Baltimore, Maryland, United States, 21229
Contact: Seema Shahi, RN    410-737-0053    s.shahi@ddamd.com   
Principal Investigator: Vijay Narayen, M.D.         
Metropolitan Gastroenterology Group Recruiting
Chevy Chase, Maryland, United States, 20815
Contact: Cindy Coates, BS, CCRC    301-652-5520    cindy.coates@capitaldigestivecare.com   
Contact: Shalee Blakeney    301-652-5520    shalee.blakeney@capitaldigestivecare.com   
Principal Investigator: Robert Hardi, M.D., CPI         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48377
Contact: Rebecca Fleckenstein, RN    248-344-2364    rflecke1@hfhs.com   
Contact: Dana Drysdale    248-344-2364      
Principal Investigator: Amit Bhan, M.D.         
United States, Mississippi
Digestive Health Care Recruiting
Ocean Springs, Mississippi, United States, 39564
Contact: Luan Brown, RN    228-872-6291    Lbrowndhc@yahoo.com   
Principal Investigator: Alfred E. McNair, Jr., M.D.         
United States, New York
Montefiore Hospital Recruiting
Bronx, New York, United States, 10467
Contact: Mustafa Alani, MD    347-671-8231    malani@montefiore.org   
Contact: Mortadha Abd, MD    347-671-8231    malani@montefiore.org   
Principal Investigator: Daniel Behin, MD         
United States, Rhode Island
Omega Medical Research Recruiting
Warwick, Rhode Island, United States, 02886
Contact: Johnna Pezullo, BSN, RN    401-739-9350 ext 228    Johnna@omegamedicalresearch.com   
Principal Investigator: Eric B Newton, MD         
United States, Virginia
Bon Secours Health System Recruiting
Richmond, Virginia, United States, 23226
Contact: Chantelle Lands, RN, MSN    804-928-3335    chantelle_lands@bshsi.org   
Contact: Denise Doyle    804-594-3070    Denise_Doyle@bshsi.org   
Principal Investigator: Bimaljit Sandhu, MD         
Sponsors and Collaborators
Exalenz Bioscience LTD.
Investigators
Study Director: Dan Peres, M.D. Exalenz Bioscience Director of Clinical Affairs
  More Information

No publications provided

Responsible Party: Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier: NCT02010112     History of Changes
Other Study ID Numbers: DM-MPBA-0813
Study First Received: December 5, 2013
Last Updated: March 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Exalenz Bioscience LTD.:
H.Pylori

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

ClinicalTrials.gov processed this record on April 15, 2014