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

Phase 3

Completed

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.

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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Specificity as Described as the Accuracy of the Breath Test in Detecting Absence of H.Pylori Infection Compared to Biopsy	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
Overall Agreement in Determining Presence or Absence of H.Pylori Infection Compared to Biopsy	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
Sensitivity is Described as the Accuracy of the Breath Test in Detecting H.Pylori Infection Compared to Biopsy	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

Secondary Outcome Measures

Name	Time	Method

Locations (13): Del Sol Research Management
🇺🇸
Tucson, Arizona, United States
Ventura Clinical Trials
🇺🇸
Ventura, California, United States
Innovative Clincal Research
🇺🇸
Lafayette, Colorado, United States
Palmetto Research
🇺🇸
Hialeah, Florida, United States
Hope Clinical Research
🇺🇸
Kissimmee, Florida, United States
Metropolitan Gastro Group
🇺🇸
Chevy Chase, Maryland, United States
Gasrtrenetrology Associates of Western Michigan, West Michigan Clinical Research Center
🇺🇸
Wyoming, Michigan, United States
Digestive Disease Care
🇺🇸
New Hyde Park, New York, United States
Great Lakes Medical Research
🇺🇸
Willoughby, Ohio, United States
Innovative Clinical Research
🇺🇸
Rapid City, South Dakota, United States
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Del Sol Research Management
🇺🇸Tucson, Arizona, United States