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

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT05674123
Collaborator
National Cancer Institute (NCI) (NIH)
2
Enrollment
1
Location
1
Arm
28.8
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Colonoscopy
  • Procedure: Endoscopic Ultrasound
  • Other: Medical Chart Review
  • Other: Medical Device Usage and Evaluation
  • Procedure: Resection
 N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
Feasibility of Transanal Robot-Assisted Resection of Distal Colorectal Lesions Using the Medrobotics Flex® System: A Pilot Study
Actual Study Start Date :
Jan 15, 2020
Actual Primary Completion Date :
Jun 10, 2022
Actual Study Completion Date :
Jun 10, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Procedure: Colonoscopy
Undergo colonoscopy

Procedure: Endoscopic Ultrasound
Undergo rectal endoscopic ultrasound
Other Names:
  • endosonography
  • EUS

    • Other: Medical Chart Review
    Ancillary studies
    Other Names:
  • Chart Review

    • Other: Medical Device Usage and Evaluation
    Undergo resection with the Flex Robotic System

    Procedure: Resection
    Undergo resection with the Flex Robotic System
    Other Names:
  • Robot-assisted surgical Resection

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rates of complete en bloc resection [Up to 2 years]

      Rates of complete en bloc resection

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Louis M Wong Kee Song, Mayo Clinic in Rochester

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05674123
    Other Study ID Numbers:
    • 19-009663
    • NCI-2022-09474
    • 19-009663
    First Posted:
    Jan 6, 2023
    Last Update Posted:
    Jan 12, 2023
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Jan 12, 2023