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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-09474 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 19-009663 | Other Identifier | Mayo Clinic in Rochester |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy | Procedure | Undergo colonoscopy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louis M Wong Kee Song | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Endoscopic Ultrasound |
| Procedure |
Undergo rectal endoscopic ultrasound |
|
|
| Medical Chart Review | Other | Ancillary studies |
|
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| Medical Device Usage and Evaluation | Other | Undergo resection with the Flex Robotic System |
|
| Resection | Procedure | Undergo resection with the Flex Robotic System |
|
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| D061765 | Endoscopic Ultrasound-Guided Fine Needle Aspiration |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D044963 | Biopsy, Fine-Needle |
| D001707 | Biopsy, Needle |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D061705 | Image-Guided Biopsy |
| D013048 | Specimen Handling |
| D018084 | Ultrasonography, Interventional |
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D008919 | Investigative Techniques |
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