Randomized Trial Comparing Next Generation Fluoroscopy System With Conventional Fluoroscopy System in Fluoroscopy-guided Endoscopic Procedures
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Fluoroscopy is an integral part of both basic and advanced gastrointestinal endoscopy procedures. Given the risks of radiation exposure and inherent limitations of preventive measures, there is a need for additional effective protective methods. In this randomized trial, we will be comparing radiation exposure between a next generation fluoroscopy system and conventional fluoroscopy system during fluoroscopy-guided endoscopic procedures.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥ 18 years
• Patients undergoing fluoroscopy-guided endoscopic procedure
• Physicians and anesthesia staff participating in endoscopic procedures
Locations
United States
Florida
Orlando Health Digestive Health Institute
RECRUITING
Orlando
Contact Information
Primary
Ji Young Bang
jiyoung.bang@orlandohealth.com
321-842-2273
Backup
Barbara J Broome
Barbara.Broome@orlandohealth.com
321-841-3742
Time Frame
Start Date: 2026-05
Estimated Completion Date: 2028-04
Participants
Target number of participants: 108
Treatments
Active_comparator: Next generation fluoroscopy system
Patients will undergo fluroscopy-guided endoscopic procedure using the next generation fluoroscopy system (Soteria, Omega Medical Imaging).
Active_comparator: Conventional fluoroscopy system
Patients will undergo fluroscopy-guided endoscopic procedure using conventional fluoroscopy system (OEC Elite, GE Healthcare).
Related Therapeutic Areas
Sponsors
Leads: Orlando Health, Inc.