The Magnetic Flexible Endoscope: Phase 1 First-in-Human… : Official journal of the American College of Gastroenterology | ACG
t-in-human clinical trial to assess platform safety and tolerability. METHODS: Platform: The MFE contains an internal permanent magnet, camera, illumination module, and channels for instruments, insufflation/camera cleaning, irrigation, and suction. A robotic arm maneuvers a second permanent magnet coupled to the MFE. System software facilitates controlled intelligent magnetic actuation. Experiment: 5 patients scheduled for screening colonoscopy (ICD-10 z12.11) were enrolled. Patients underwent standard of care colonoscopy with monitored anesthesia care. On withdrawal of the colonoscope, sedation was stopped, and after colonoscope removal, the MFE was inserted into the colon through the anus. The MFE was advanced through the colon while the patient was unsedated. After colon traversal, the MFE was withdrawn. Outcomes of interest included safety and tolerability of the MFE, participant sentiment through structured interview, platform usability, and robot pose data. RESULTS: All patients
