NCT05674123

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

Completed NA Last updated 12 January 2023

What this trial tests

NA trial testing Colonoscopy in Colorectal Neoplasm in 2 participants. Completed in 10 June 2022.

Timeline

15 January 2020

Primary endpoint
10 June 2022

10 June 2022

Quick facts

Lead sponsor	Mayo Clinic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	device feasibility
Enrollment	2
Start date	15 January 2020
Primary completion	10 June 2022
Estimated completion	10 June 2022
Sites	1 location across United States

Drugs / interventions tested

• Colonoscopy
• Endoscopic Ultrasound
• Medical Chart Review
• Medical Device Usage and Evaluation
• Resection

Conditions studied

• Colorectal Neoplasm — all drugs for Colorectal Neoplasm →

Sponsor

Mayo Clinic

Who can join

22 and older, any sex, with Colorectal Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.