Evaluating the Safety and Effectiveness of the Flex Robotic System for the Surgical Removal of Colorectal Lesions

Feasibility of Transanal Robot-Assisted Resection of Distal Colorectal Lesions Using the Medrobotics Flex® System: A Pilot Study

This clinical trial assesses the safety and effectiveness of a new device called the Flex Robotic System in the surgical removal (resection) of colorectal lesions. When an area of abnormal tissue called a lesion is found in the colon or rectum, it is often not known if the lesion is cancerous or non-cancerous. Recommendation to remove the lesion may be made. Current methods of resection can be challenging and time-consuming. The Flex Robotic System is a new device that provides a stable working environment, better ability to grasp and cut lesions, and better tissue handling when performing a resection. The Flex Robotic system may be more effective at removing colorectal lesions than standard resection techniques.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasm
• Intervention / Treatment: Procedure: Colonoscopy; Other: Medical Chart Review; Procedure: Endoscopic Ultrasound; Other: Medical Device Usage and Evaluation; Procedure: Resection

Detailed Description

PRIMARY OBJECTIVE:

I. To assess the rates of complete en bloc resection and adverse events of the Flex Robotic System for distal colorectal lesions.

OUTLINE:

Patients undergo resection with Flex Robotic System on study. Patients also undergo colonoscopy with or without rectal endoscopic ultrasound at screening.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age >= 22 years (minimum age approved for use)
• Polypoid (0-Is) and non-polypoid (0-IIa, 0-IIb and 0-IIc) lateral spreading lesions according to Paris classification
• Colorectal lesions situated between 5 and 15 cm from the dentate line
• Colorectal mucosal lesions ranging from 1.5 to 7 cm in maximum diameter
• Colorectal subepithelial lesions < 2 cm in size
• Absence of uncorrectable bleeding disorder or coagulopathy
• Platelet count > 50,000
• International normalized ratio (INR) < 1.5
• Ability to give informed consent

Exclusion Criteria:

• Inability to receive general anesthesia
• Presence of medical conditions for which a transanal approach is contraindicated (e.g., anal stricture, radiation proctopathy)
• Excavated (0-III) colorectal lesions according to Paris classification
• Suboptimal colon preparation
• Clinical discretion of the provider

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Device Feasibility (Flex Robotic System); Patients undergo resection with Flex Robotic System on study. Patients also undergo colonoscopy with or without rectal endoscopic ultrasound at screening.

Procedure: Colonoscopy; Undergo colonoscopy; Other: Medical Chart Review; Ancillary studies; Other Names: Chart Review; Procedure: Endoscopic Ultrasound; Undergo rectal endoscopic ultrasound; Other Names: endosonography; EUS; Other: Medical Device Usage and Evaluation; Undergo resection with the Flex Robotic System; Procedure: Resection; Undergo resection with the Flex Robotic System; Other Names: Robot-assisted surgical Resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of complete en bloc resection	Rates of complete en bloc resection	Up to 2 years
Incidence of adverse events	The primary endpoint will be the Incidence of adverse events using the Flex Robotic System for distal colorectal lesions.	Up to 2 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Louis M Wong Kee Song, Mayo Clinic in Rochester

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Actual): June 10, 2022
• Study Completion (Actual): June 10, 2022

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 6, 2023

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 19-009663 (Other Identifier: Mayo Clinic in Rochester); NCI-2022-09474 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No