An interventional study of Colonoscopy and Endoscopic Ultrasound in Colorectal Neoplasm, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2023-01-12.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Device feasibility
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 2 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Undergo colonoscopy
Undergo rectal endoscopic ultrasound
Also known as: endosonography, EUS
Ancillary studies
Also known as: Chart Review
Undergo resection with the Flex Robotic System
Undergo resection with the Flex Robotic System
Also known as: Robot-assisted surgical Resection
Rates of complete en bloc resection
Rates of complete en bloc resection
Time frame: 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.
Time frame: Up to 2 years
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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