The Magnetic Flexible Endoscope: Phase 1 First-in-Human Clinical Trial.

Abstract

Background and aims: Magnetic actuation of endoscopes is promising-as the endoscope can be pulled from its front. Our team developed a novel Magnetic Flexible Endoscope (MFE) that uses magnetic field sensing, robotic control, and real-time image processing for colonoscopy. We conducted a Phase 1 first-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: Five patients scheduled for screening colonoscopy (ICD-10 z12.11) were enrolled. Patients underwent standard of care colonoscopy with monitored anesthesia care. Upon withdrawal of the colonoscope, sedation was stopped, and after colonoscope removal, the MFE was inserted into the colon via 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 After colon traversal, the MFE was withdrawn.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 via structured interview, platform usability, and robot pose data.

Results: All patients underwent successful standard of care colonoscopy. All patients were awake and alert for MFE colonoscopy; tolerating the exam well without discomfort, pain, or other complaint. There were no adverse events or trauma. The system was robust without software or function failure.

Conclusion: The MFE successfully traversed the human colon without adverse event or patient discomfort. System performance was successful without unanticipated events. This is the first time safety and tolerability of the novel platform has been demonstrated in vivo. ClinicalTrials.gov (NCT05833789).