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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Neoplasm

Intervention / Treatment
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* Procedure: Colonoscopy
* Procedure: Endoscopic Ultrasound
* Other: Medical Chart Review
* Other: Medical Device Usage and Evaluation
* Procedure: Resection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device Feasibility (Flex Robotic System)<br>Patients undergo resection with Flex Robotic System on study. Patients also undergo colonoscopy with or without rectal endoscopic ultrasound at screening. | Procedure: Colonoscopy<br>* Undergo colonoscopy<br>Procedure: Endoscopic Ultrasound<br>* Undergo rectal endoscopic ultrasound<br>* Other names: EUS;Other: Medical Chart Review<br>* Ancillary studies<br>* Other names: Chart Review;Other: Medical Device Usage and Evaluation<br>* Undergo resection with the Flex Robotic System<br>Procedure: Resection<br>* Undergo resection with the Flex Robotic System<br>* Other names: Robot-assisted surgical Resection;|

What is the study measuring?
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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 |