Background: Use of magnetic fields for endoscope actuation has been 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 (CLS). While the platform has been successful in ex-vivo and in-vivo animal/cadaver models, safety and tolerability in patients is unknown. Therefore, we conducted a Phase 1 first-in-human clinical trial at our tertiary care academic medical center.

Methods:
Platform: The MFE contains an internal permanent magnet (PM), camera, illumination module, and channels for instruments, insufflation/camera cleaning, irrigation, and suction. A robotic arm maneuvers a second PM to manipulate the MFE [Fig 1]. System software facilitates intelligent-magnetic actuation via a handheld controller (thumb operated four directional joystick with hydraulic controls and depressible button for forward motion).

Experiment: Five patients scheduled to undergo screening CLS (ICD-10 z12.11) at our tertiary care academic medical center were enrolled. Patients underwent their standard of care CLS with monitored anesthesia care using propofol. Upon withdrawal of the conventional colonoscope (CC), sedation was stopped, and after CC removal, the MFE was inserted into the colon via the anus. The MFE was then advanced through the colon while the patient was unsedated [Fig 2]. After colon traversal, the MFE was withdrawn via the anus and a series of surveys were completed by the patient and provider. Outcomes of interest included safety and tolerability of the MFE exam--including discomfort/pain (Wong-Baker FACES pain scale), qualitative assessment of participant sentiment via structured interview, platform usability (NASA Task Load Index (TLX)), and robot pose data/processing. ClinicalTrials.gov ID: NCT05833789.

Results: All 5 patients (4 female, 1 male; median age: 47 [45, 66]) underwent successful CLS with the CC. All patients were alert and awake for the MFE CLS. All patients tolerated MFE CLS well without discomfort, pain, or other complaint (FACES score 0 [0,2]). There were no adverse events or trauma. The system was robust, necessitating manual reset infrequently (total n=2), and no system software failures were noted. MFE insufflation, irrigation, lens cleaning, and illumination were successful. MFE operator TLX indicated low mental demand (31 [28,33]), low physical demand (44 [29,47]), and low temporal demand (28 [25,31]).

Conclusion: The MFE successfully traversed the human colon without adverse event or patient discomfort. All patients tolerated the MFE well without sedation. System performance was successful with no unanticipated events. This is the first time safety and tolerability of the novel MFE platform has been demonstrated in human patients. Plans for next phase human trials are underway.

Fig 1. The MFE platform

Fig 2. MFE actively traversing the human colon

Simone Caló

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