Post-Market Clinical Follow-Up to Access & Visualize the Anus, Rectum, & Distal Colon During Transanal Procedures

Medrobotics Corporation20 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Disease or Lesions of the Anus, Rectum, or Distal Colon

Interventions

Transanal endoscopic surgical procedureDEVICE

Resection of tumors or lesions

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (2)

Univsersity of Nevada School of Medicine

Las Vegas, Nevada, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Outcomes

Primary Outcomes

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

Time frame: 0-24 hours

Secondary Outcomes

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

Time frame: 0-24 hours

Data from ClinicalTrials.gov

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