Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Single-Center, Exploratory Study of EndoChoice's Upper and Lower Gastrointestinal Endoscopic Systems Utilizing EndoChoice's Full Spectrum Optical Technology
The investigational devices are EndoChoice gastrointestinal endoscopic systems that are similar in their fit, form, and functions to the corresponding commercially available models with the exception of the EndoChoice's proprietary Optical system that enhances their field of view.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopy exploratory single arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FuseĀ® Colonoscope | Device | Endoscopic diagnostic procedures for lower GI tract |
|
| Measure | Description | Time Frame |
|---|---|---|
| Performance, usability and ease of use (performance questionnaire) | The performance of the device is assessed via a performance questionnaire which the recruiting (and treatment providing) physician will answer | Through study completion, estimate average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (adverse and severe adverse events) | Establish safety of the device by measure of adverse and severe adverse events, if such occur. | Through study completion, estimate average of 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| FuseĀ® Gastroscope | Device | Endoscopic diagnostic procedures for upper GI tract |
|