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NCT Number: NCT05674123

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

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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Key information

Conditions

Colorectal Neoplasm Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

colonoscopy

Procedure

Undergo colonoscopy

Endoscopic Ultrasound

Procedure

Undergo rectal endoscopic ultrasound

Other names: endosonography, EUS

medical chart review

Other

Ancillary studies

Other names: Chart Review

Medical Device Usage and Evaluation

Other

Undergo resection with the Flex Robotic System

Resection

Procedure

Undergo resection with the Flex Robotic System

Other names: Robot-assisted surgical Resection

Primary outcomes

  1. Rates of complete en bloc resection

    Time frame: Up to 2 years

    Rates of complete en bloc resection

  2. Incidence of adverse events

    Time frame: Up to 2 years

    The primary endpoint will be the Incidence of adverse events using the Flex Robotic System for distal colorectal lesions.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 6, 2023
Registry last updated
Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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