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

Area of Science:

• Medical Devices
• Robotics
• Gastroenterology

Background:

• Magnetic actuation offers a promising approach for endoscopic procedures.
• A novel magnetic flexible endoscope (MFE) was developed for colonoscopy, integrating magnetic sensing, robotic control, and image processing.
• A Phase 1 clinical trial was initiated to evaluate the MFE's safety and tolerability.

Purpose of the Study:

• To assess the safety and tolerability of the novel magnetic flexible endoscope (MFE) in a first-in-human clinical trial.
• To evaluate participant experience and system usability during MFE colonoscopy.

Main Methods:

• The MFE system includes an internal magnet, camera, illumination, and instrument channels, maneuvered by an external robotic arm.
• Five patients undergoing screening colonoscopy were enrolled.
• The MFE was inserted and advanced through the colon while patients were unsedated, following standard colonoscopy.

Main Results:

• All patients tolerated the MFE colonoscopy well without discomfort, pain, or adverse events.
• The MFE successfully traversed the colon in all participants.
• The system demonstrated robust performance without software or functional failures.

Conclusions:

• The magnetic flexible endoscope (MFE) is safe and well-tolerated for unsedated colonoscopy in humans.
• This study marks the first in vivo demonstration of the MFE platform's safety and efficacy.
• The MFE shows potential as a novel tool for colonoscopic examinations.