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

NCT05674123 | Completed DMC FDA Device

• 2 other identifiers: 19-009663NCI-2022-09474
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Device Feasibility (Flex Robotic System)

EXPERIMENTAL

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

Procedure: Colonoscopy; Procedure: Endoscopic Ultrasound; Other: Medical Chart Review; Other: Medical Device Usage and Evaluation; Procedure: Resection

Interventions

Colonoscopy PROCEDURE

Undergo colonoscopy

Device Feasibility (Flex Robotic System)

Endoscopic Ultrasound PROCEDURE

Undergo rectal endoscopic ultrasound

Also known as: endosonography, EUS

Device Feasibility (Flex Robotic System)

Medical Chart Review OTHER

Ancillary studies

Also known as: Chart Review

Device Feasibility (Flex Robotic System)

Medical Device Usage and Evaluation OTHER

Undergo resection with the Flex Robotic System

Device Feasibility (Flex Robotic System)

Resection PROCEDURE

Undergo resection with the Flex Robotic System

Also known as: Robot-assisted surgical Resection

Device Feasibility (Flex Robotic System)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy; Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Investigative Techniques

Study Officials

• Louis M Wong Kee Song

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: January 6, 2023
• Study Start: January 15, 2020
• Primary Completion: June 10, 2022
• Study Completion: June 10, 2022
• Last Updated: January 12, 2023

Record last verified: 2022-12

Locations

US (1)