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Single Blind, Randomized Control Study is designed to evaluate the tolerability of the Celero Systems' modified Health-Dx™ (mHDx) capsule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| modified Health- Dx™ (mHDx) study capsule | Experimental |
| |
| modified Health- Dx™ (mHDx) control capsule | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| modified Health- Dx™ (mHDx) study capsule | Device | The Study mHDx capsule has a mechanism that allows the mHDx to remain resident in the stomach for no more than six (6) hours. After this residency period, the Study mHDx will disassemble and pass safely through the subject's gastrointestinal system. |
| Measure | Description | Time Frame |
|---|---|---|
| The difference, if any, in tolerability between the Study and Control as reported via the study questionnaire. mHDx as reported by the subjects. | day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
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| modified Health- Dx™ (mHDx) control capsule | Device | The Control mHDX capsule does not have a functional residency mechanism so it will disassemble once safely through the esophagus (within 10 minutes) and will then pass safely through the subject's gastrointestinal system. |
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