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

• Conditions: Disease or Lesions of the Anus, Rectum, or Distal Colon
• Interventions: Device: Transanal endoscopic surgical procedure

• Registration Number: NCT03323060
• Lead Sponsor: Medrobotics Corporation

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-11
• Study First Submitted: 2017-10-20
• Study First Submitted QC: 2017-10-23
• Study First Posted: 2017-10-26
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-13
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Male and/or females ≥ 22 yrs old	Transanal endoscopic surgical procedure	≥ 22 years of age requiring transanal procedures in the areas of the anus, rectum, and distal colon Transanal endoscopic surgical procedure

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

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