Disease or Lesions of the Anus, Rectum, or Distal Colon
Conditions
Brief summary
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
Interventions
DEVICETransanal endoscopic surgical procedure
Resection of tumors or lesions
Sponsors
Medrobotics Corporation
Study design
Observational model
FAMILY_BASED
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 22 years of age * Candidate for transanal procedures in the areas of the anus, rectum, and distal colon.
Exclusion criteria
* Candidates are excluded if they \< 22 years of age and do not meet criteria for transanal surgery in the anus, rectum, and distal colon
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Access and Visualization | 0-24 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance of transanal surgical procedure | 0-24 hours | Ability to complete the planned transanal surgical procedure using the Flex Robotic System, Flex Rectoscope and Flex compatible flexible instruments |
Countries
United States
Outcome results
None listed