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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-15

Study Completion Date

2022-06-10

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.

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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.

Conditions

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Colorectal Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Device Feasibility (Flex Robotic System)

Patients undergo resection with Flex Robotic System on study. Patients also undergo colonoscopy with or without rectal endoscopic ultrasound at screening.

Group Type EXPERIMENTAL

Colonoscopy

Intervention Type PROCEDURE

Undergo colonoscopy

Endoscopic Ultrasound

Intervention Type PROCEDURE

Undergo rectal endoscopic ultrasound

Medical Chart Review

Intervention Type OTHER

Ancillary studies

Medical Device Usage and Evaluation

Intervention Type OTHER

Undergo resection with the Flex Robotic System

Resection

Intervention Type PROCEDURE

Undergo resection with the Flex Robotic System

Interventions

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Colonoscopy

Undergo colonoscopy

Intervention Type PROCEDURE

Endoscopic Ultrasound

Undergo rectal endoscopic ultrasound

Intervention Type PROCEDURE

Medical Chart Review

Ancillary studies

Intervention Type OTHER

Medical Device Usage and Evaluation

Undergo resection with the Flex Robotic System

Intervention Type OTHER

Resection

Undergo resection with the Flex Robotic System

Intervention Type PROCEDURE

Other Intervention Names

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endosonography EUS Chart Review Robot-assisted surgical Resection

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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No