Randomized Trial Comparing Next Generation Fluoroscopy System With Conventional Fluoroscopy System in Fluoroscopy-guided Endoscopic Procedures

What this Trial Is About

Fluoroscopy plays a key role in both basic and advanced gastrointestinal endoscopic procedures, but it exposes patients, doctors, and support staff to ionizing radiation, which carries health risks including increased cancer risk. This research compares radiation exposure between a next generation fluoroscopy system and a conventional system to find safer methods for these procedures. The study is randomized and double-blinded, focusing on reducing radiation doses during fluoroscopy-guided endoscopic interventions. Participants will undergo fluoroscopy-guided endoscopic procedures using either the next generation fluoroscopy system (Soteria E-View) or a conventional fluoroscopy system (OEC Elite). The advanced system incorporates artificial intelligence, improved hardware, fluoroless positioning, reduced frame rates, and robotic design to minimize radiation exposure. The study compares these two systems during the same types of procedures to evaluate differences in radiation scatter and exposure. During the study, radiation scatter, radiation exposure, total procedure time, and fluoroscopy duration will be measured and compared between groups. Participants include patients undergoing these endoscopic procedures as well as physicians and anesthesia staff involved. The study began in May 2026 and will continue until April 2028, with data collected on the day of each procedure to assess the safety and efficiency of the fluoroscopy systems used.

Randomized Trial of Next Generation Fluoroscopy System vs. Conventional Fluoroscopy System in Endoscopy