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The aim of the study is to confirm that the new generation state of the art breath analyzer gives equivalent results to the previous model of the Exalenz breath analyzer.
Healthy and chronic liver disease subjects of all grades will be tested to see that the two devices give equivalent results in both devices. Subjects will be connected to both devices at the same time and will be tested for one hour.
The breath test includes automatic baseline breath collection, 13C-Methacetin ingestion in solution and breath collection post ingestion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLD with MPBA and BID | Experimental | Chronic Liver Disease (CLD) patients of all degrees will be offered to be tested on the MPBA (multi purpose breath analyzer) and BID (BreathID) on a walk- in basis with , proving they meet inclusion/exclusion criteria. |
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| HV with MPBA and BID | Experimental | Healthy volunteers (HV) with no known liver disease will undergo the breath test with the MPBA and the BID before and after substrate ingestion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MPBA System | Device | MPBA is the new generation Multi Purpose Breath Analyzer |
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| Measure | Description | Time Frame |
|---|---|---|
| DOB Peak | The DOB (Delta over Baseline) is measured before and after ingestion of challenging test substrate: 13C- Methacetin. The peak of the DOB is indicative of liver health. | One hour |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events related to breath test substrate | Adverse events within 48 hours of the breath test will be recorded | 48 hours |
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Inclusion Criteria:
Over 18 years of age
Ability and willingness to sign the Informed Consent Form
For patient group:
a. Known chronic liver disease (based on medical history)
For healthy volunteers:
3.b. No known liver disease (based on medical history)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saleh Daher, MD | Hadassah Medical Organization | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assaf Harofe Medical Center | Tzrifin | Israel |
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| BreathID | Device | BreathID is the name of the original Exalenz breath analyzer system |
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