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

Colorectal Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05674123
• Other study ID #: 19-009663
• Secondary ID: NCI-2022-0947419
• Status: Completed
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: June 10, 2022

Study information

• Verified date: December 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: June 10, 2022
• Est. primary completion date: June 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasm
• Colorectal Neoplasms

Intervention

Procedure:
• Colonoscopy
Undergo colonoscopy
• Endoscopic Ultrasound
Undergo rectal endoscopic ultrasound

Other:
• Medical Chart Review
Ancillary studies
• Medical Device Usage and Evaluation
Undergo resection with the Flex Robotic System

Procedure:
• Resection
Undergo resection with the Flex Robotic System

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of complete en bloc resection	Rates of complete en bloc resection	Up to 2 years
Primary	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