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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 14, 2014
Last verified: September 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: October 2014
Estimated Primary Completion Date: September 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
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: 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: Mortadha Abd, MD    347-671-8231    mabd@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, Tennessee
Clinical Research Solutions Recruiting
Jackson, Tennessee, United States, 38305
Contact: Vickie Grisby, RN    731-431-3334    vgrigsby@crssites.com   
Contact: Amy Arnold, BS, CCRC    731-431-3334    aarnold@crssites.com   
Principal Investigator: John Souders, M.D.         
United States, Texas
JM Research Recruiting
Houston, Texas, United States, 77011
Contact: Gilberto Botello    713-234-1518    gilberto@jmresearch.org   
Contact: Ingrid Badillo       ingrid@jmresearch.org   
Principal Investigator: Jose Flores, M.D.         
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: September 14, 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 September 18, 2014