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A new method of breath collection for testing for Helicobacter Pylori infection has been developed by Exalenz. In this study, it will be compared to the gold standard- endoscopy results to prove its accuracy.
This study will validate a breath collection method by comparing a newly developed breath test kit, IDkit:Hpâ„¢ TWO using breath collection bags, to congruent biopsy results (a composite reference standard by analyzing specimens with microbial culture, histological examination and rapid urease test- RUT) in detecting H.Pylori
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial Diagnosis Cohort | Experimental | Subjects with clinical indication of H.pylori infection will undergo breath test compared to routine clinical standard of care- endoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breath Test Collection bags | Other | Breath Collection bags will be used to collect breath of subjects before and after ingestion of 13-C breath test substrate |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall percent agreement | The primary study endpoint is the performance measure (overall percent agreement) in initial diagnosis (presence/ absence of H.pylori) between biopsy results and bag mode breath test. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| overall percent agreement | The performance measure (overall percent agreement) in post-therapy diagnosis (presence/ absence of H.pylori) between the Dual Mode BreathID® Hp System when using only one pair of IDkit:Hp™ TWO breath collection bags measured within 9 days and congruent biopsy results | 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melina Arazy, M.D. | VP of clinical affairs, Exalenz | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive Disease Associates, PA | Baltimore | Maryland | 21229 | United States | ||
| Metropolitan Gastroenterology Group |
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|
| Chevy Chase |
| Maryland |
| 20815 |
| United States |
| Henry Ford Health System | Detroit | Michigan | 48377 | United States |
| Digestive Health Care | Ocean Springs | Mississippi | 39564 | United States |
| Montefiore Hospital | The Bronx | New York | 10467 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886 | United States |
| Clinical Research Solutions | Jackson | Tennessee | 38305 | United States |
| JM Research | Houston | Texas | 77011 | United States |
| Bon Secours Health System | Richmond | Virginia | 23226 | United States |