A Study to Determine the Feasibility of Transanal Robot-assisted Resection of Distal Colorectal Lesions Using the Medrobotics Flex® System
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-009663
NCT ID: NCT05674123
Sponsor Protocol Number: 19-009663
About this study
The purpose of this study is to assess the rates of complete en bloc resection and adverse events of the Flex Robotic System for distal colorectal lesions.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 and 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Louis Wong Kee Song, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available