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

Completed · Phase 3

Conditions studied: Helicobacter Pylori Infection

In brief

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.

Key facts

Study ID

NCT02528721

Run by

Meridian Bioscience, Inc.

People needed

282

Starts

2015-10-01

Expected to finish

2016-07-01

Last updated by the study team

2022-12-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Digestive Disease Center of South Texas, P.L.L.C — San Antonio, Texas, United States
• Barzilai Medical center — Ashkelon, Israel
• Assaf Harofe Medical Center — Tzrifin, Israel

Full record on ClinicalTrials.gov

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