Clinical trial NCT02528721: Exalenz Lab Mode System Compared to Biopsy for H.Pylori Detection
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Helicobacter Pylori Infection
Lead sponsor: Meridian Bioscience, Inc.
Sponsor class: INDUSTRY
First posted: 2015-08-19
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Sensitivity is Described as the Accuracy of the Breath Test in Detecting H.Pylori Infection Compared to Biopsy
timeFrame: 9 months
measure: Specificity as Described as the Accuracy of the Breath Test in Detecting Absence of H.Pylori Infection Compared to Biopsy
timeFrame: 9 months
measure: Overall Agreement in Determining Presence or Absence of H.Pylori Infection Compared to Biopsy
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Del Sol Research Management
state: Arizona
city: Ventura
country: United States
facility: Ventura Clinical Trials
state: California
city: Lafayette
country: United States
facility: Innovative Clincal Research
state: Colorado
city: Hialeah
country: United States
facility: Palmetto Research
state: Florida
city: Kissimmee
country: United States
facility: Hope Clinical Research
state: Florida
city: Chevy Chase
country: United States
facility: Metropolitan Gastro Group
state: Maryland
city: Wyoming
country: United States
facility: Gasrtrenetrology Associates of Western Michigan, West Michigan Clinical Research Center
state: Michigan
city: New Hyde Park
country: United States
facility: Digestive Disease Care
state: New York
city: Willoughby
country: United States
facility: Great Lakes Medical Research
state: Ohio
city: Rapid City
country: United States
facility: Innovative Clinical Research
state: South Dakota
city: San Antonio
country: United States
facility: Digestive Disease Center of South Texas, P.L.L.C
state: Texas
city: Ashkelon
country: Israel
facility: Barzilai Medical center
city: Tzrifin
country: Israel
facility: Assaf Harofe Medical Center
Study officials:
References: