Helicobacter Pylori Infection Clinical Trial
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
NCT number | NCT02528721 |
Other study ID # | DM2-HP-0715 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | October 2015 |
Est. completion date | July 2016 |
Verified date | December 2022 |
Source | Meridian Bioscience, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 282 |
Est. completion date | July 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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: - 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 |
Country | Name | City | State |
---|---|---|---|
Israel | Barzilai Medical center | Ashkelon | |
Israel | Assaf Harofe Medical Center | Tzrifin | |
United States | Metropolitan Gastro Group | Chevy Chase | Maryland |
United States | Palmetto Research | Hialeah | Florida |
United States | Hope Clinical Research | Kissimmee | Florida |
United States | Innovative Clincal Research | Lafayette | Colorado |
United States | Digestive Disease Care | New Hyde Park | New York |
United States | Innovative Clinical Research | Rapid City | South Dakota |
United States | Digestive Disease Center of South Texas, P.L.L.C | San Antonio | Texas |
United States | Del Sol Research Management | Tucson | Arizona |
United States | Ventura Clinical Trials | Ventura | California |
United States | Great Lakes Medical Research | Willoughby | Ohio |
United States | Gasrtrenetrology Associates of Western Michigan, West Michigan Clinical Research Center | Wyoming | Michigan |
Lead Sponsor | Collaborator |
---|---|
Meridian Bioscience, Inc. |
United States, Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity is Described as the Accuracy of the Breath Test in Detecting H.Pylori Infection Compared to Biopsy | 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 | 9 months | |
Primary | Specificity as Described as the Accuracy of the Breath Test in Detecting Absence of H.Pylori Infection Compared to Biopsy | 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 | 9 months | |
Primary | Overall Agreement in Determining Presence or Absence of H.Pylori Infection Compared to Biopsy | 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 | 9 months |
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