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

Not Applicable

Completed

• Conditions: Colorectal Neoplasm
• Interventions: Procedure: Colonoscopy; Procedure: Endoscopic Ultrasound; Other: Medical Chart Review; Other: Medical Device Usage and Evaluation; Procedure: Resection

• Registration Number: NCT05674123
• Lead Sponsor: Mayo Clinic

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-01-15
• Primary Completion: 2022-06-10
• Study Completion: 2022-06-10
• Status Verified: 2022-12
• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2023-01-05
• Study First Posted: 2023-01-06
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device Feasibility (Flex Robotic System)	Colonoscopy	Patients undergo resection with Flex Robotic System on study. Patients also undergo colonoscopy with or without rectal endoscopic ultrasound at screening.
Device Feasibility (Flex Robotic System)	Medical Chart Review	Patients undergo resection with Flex Robotic System on study. Patients also undergo colonoscopy with or without rectal endoscopic ultrasound at screening.
Device Feasibility (Flex Robotic System)	Medical Device Usage and Evaluation	Patients undergo resection with Flex Robotic System on study. Patients also undergo colonoscopy with or without rectal endoscopic ultrasound at screening.
Device Feasibility (Flex Robotic System)	Endoscopic Ultrasound	Patients undergo resection with Flex Robotic System on study. Patients also undergo colonoscopy with or without rectal endoscopic ultrasound at screening.
Device Feasibility (Flex Robotic System)	Resection	Patients undergo resection with Flex Robotic System on study. Patients also undergo colonoscopy with or without rectal endoscopic ultrasound at screening.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States