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
To assess the safety and performance of the Medrobotics Flex Robotic System and Flex Rectoscope for accessing and visualizing the Anus, Rectum, and Distal Colon when used for Transanal procedures
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Male and/or females ≥ 22 yrs old | ≥ 22 years of age requiring transanal procedures in the areas of the anus, rectum, and distal colon Transanal endoscopic surgical procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transanal endoscopic surgical procedure | Device | Resection of tumors or lesions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Access and Visualization | Ability to access/touch with compatible flexible instruments and visualize/see with the scope/camera each of the four anatomical locations in the anus, rectum, and distal colon. The 4 areas to be accessed/touched and visualized/seen from the most proximal to the most distal are; Lower Rectum, Mid Rectum, Upper Rectum, Rectosigmoid Junction | 0-24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Performance of transanal surgical procedure | Ability to complete the planned transanal surgical procedure using the Flex Robotic System, Flex Rectoscope and Flex compatible flexible instruments | 0-24 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Subjects ≥ 22 years of age requiring transanal procedures in the areas of the anus, rectum, and distal colon
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univsersity of Nevada School of Medicine | Las Vegas | Nevada | 89102 | United States | ||
| Icahn School of Medicine at Mount Sinai |
Not provided
Not provided
Not provided
Not provided
| New York |
| New York |
| 10029 |
| United States |
| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided