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

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

Official title:

A Multicenter Post-Market Clinical Follow-Up of the Medrobotics Flex Robotic System and Flex Rectoscope Used for Accessing and Visualizing the Anus, Rectum, and Distal Colon During Transanal Procedures

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03323060
• Other study ID #: FLX-CRC-PMK-US-001
• Status: Enrolling by invitation
• Start date: October 11, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: August 2019
• Source: Medrobotics Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Transanal endoscopic surgical procedure
Resection of tumors or lesions

Locations

Country	Name	City	State
United States	Univsersity of Nevada School of Medicine	Las Vegas	Nevada
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medrobotics Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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