NCT05674123

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Colorectal Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Colonoscopy	Undergo colonoscopy
PROCEDURE	Endoscopic Ultrasound	Undergo rectal endoscopic ultrasound
OTHER	Medical Chart Review	Ancillary studies
OTHER	Medical Device Usage and Evaluation	Undergo resection with the Flex Robotic System
PROCEDURE	Resection	Undergo resection with the Flex Robotic System

Timeline

• Start date: 2020-01-15
• Primary completion: 2022-06-10
• Completion: 2022-06-10
• First posted: 2023-01-06
• Last updated: 2023-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study