Colorectal Neoplasm
Conditions
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.
Interventions
PROCEDUREColonoscopy
Undergo colonoscopy
PROCEDUREEndoscopic Ultrasound
Undergo rectal endoscopic ultrasound
OTHERMedical Chart Review
Ancillary studies
OTHERMedical Device Usage and Evaluation
Undergo resection with the Flex Robotic System
PROCEDUREResection
Undergo resection with the Flex Robotic System
Sponsors
National Cancer Institute (NCI)
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of complete en bloc resection | Up to 2 years | Rates of complete en bloc resection |
| 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. |
Countries
United States
Outcome results
None listed