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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Colonoscopy

Endoscopic Ultrasound

Medical Chart Review

Medical Device Usage and Evaluation

Resection

About this trial

This is an interventional device feasibility trial for Colorectal Neoplasm

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device Feasibility (Flex Robotic System)

Arm Description

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

Outcomes

Primary Outcome Measures

Rates of complete en bloc resection

Incidence of adverse events

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05674123

First Posted

December 12, 2022

Last Updated

January 11, 2023

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT05674123

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

January 15, 2020 (Actual)

Primary Completion Date

June 10, 2022 (Actual)

Study Completion Date

June 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

4. Oversight

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

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Neoplasm

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Device Feasibility (Flex Robotic System)

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Colonoscopy

Intervention Description

Undergo colonoscopy

Intervention Type

Procedure

Intervention Name(s)

Endoscopic Ultrasound

Other Intervention Name(s)

endosonography, EUS

Intervention Description

Undergo rectal endoscopic ultrasound

Intervention Type

Other

Intervention Name(s)

Medical Chart Review

Other Intervention Name(s)

Chart Review

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

Medical Device Usage and Evaluation

Intervention Description

Undergo resection with the Flex Robotic System

Intervention Type

Procedure

Intervention Name(s)

Resection

Other Intervention Name(s)

Robot-assisted surgical Resection

Intervention Description

Undergo resection with the Flex Robotic System

Primary Outcome Measure Information:

Title

Rates of complete en bloc resection

Description

Rates of complete en bloc resection

Time Frame

Up to 2 years

Title

Incidence of adverse events

Description

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

Time Frame

Up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Louis M Wong Kee Song

Organizational Affiliation

Mayo Clinic in Rochester

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Colorectal Neoplasm

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial