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The PillBot System is an endoscopic capsule imaging system intended for visualization of the stomach. In contrast to currently used passive capsule endoscopy systems, and FDA cleared active magnetic system, the PillBot System uses active, motorized propulsion technology to facilitate the navigation and positioning of the capsule within the stomach anatomy for imaging of the gastric mucosa by an operator
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PillBot | Experimental | Patient will swallow the PillBot and be assessed with EGD after two hours of the examination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PillBot | Device | The PillBot System uses active, motorized propulsion technology to facilitate the navigation and positioning of the capsule within the stomach anatomy for imaging of the gastric mucosa by an operator. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint | Adverse events rate during and following device use. | Up to two weeks |
| Primary Effectiveness Endpoint | Identification of the gastric anatomy landmarks (cardia, fundus, body, angulus, antrum, and pylorus) with PillBot compared to conventional endoscopy. | Through study completion, an average of two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Study Endpoints | 1. Complete gastric examination using PillBot and its passage into the duodenum. Complete gastric examination is defined as the ability to identify and distinguish lesion type (i.e., polyps, ulcers, submucosal humps, etc.), lesion size (e.g., <5mm and > 5mm) and location when using the PillBot compared with conventional endoscopy. | Through study completion, an average of two weeks |
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Inclusion Criteria:
Exclusion Criteria:
All patients who meet any of the following criteria should not be enrolled into the study:
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| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Secondary Study Endpoints | 2. Accuracy of gastric lesions detection by the RCE compared to the upper endoscopy based on independent reviewer's assessment. | Through study completion, an average of two weeks |