Exalenz Lab Mode System Compared to Biopsy for H.Pylori Detection
Public ClinicalTrials.gov record NCT02528721. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02528721
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 282 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2015 (Type not available)
- Primary completion
- Jun 2016 (Actual)
- Completion
- Jul 2016 (Actual)
- Last update posted
- Dec 20, 2022
2015 – 2016
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Del Sol Research Management | Tucson | Arizona | 85710 | — |
| Ventura Clinical Trials | Ventura | California | 93003 | — |
| Innovative Clincal Research | Lafayette | Colorado | 80026 | — |
| Palmetto Research | Hialeah | Florida | 33016 | — |
| Hope Clinical Research | Kissimmee | Florida | 34741 | — |
| Metropolitan Gastro Group | Chevy Chase | Maryland | 20815 | — |
| Gasrtrenetrology Associates of Western Michigan, West Michigan Clinical Research Center | Wyoming | Michigan | 49519 | — |
| Digestive Disease Care | New Hyde Park | New York | 11040 | — |
| Great Lakes Medical Research | Willoughby | Ohio | 44094 | — |
| Innovative Clinical Research | Rapid City | South Dakota | 57701 | — |
| Digestive Disease Center of South Texas, P.L.L.C | San Antonio | Texas | 78215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02528721, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 20, 2022 · Synced Oct 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02528721 live on ClinicalTrials.gov.