Next Generation vs Conventional Fluoroscopy for Endoscopy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new imaging system used during endoscopy procedures to help doctors view the digestive system. The goal is to determine if this next-generation fluoroscopy system (an advanced imaging technology) reduces radiation exposure compared to the conventional system. Individuals scheduled for an endoscopy with fluoroscopy might be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to advancements in medical imaging technology, potentially enhancing safety for future patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that these fluoroscopy systems are safe for endoscopic procedures?
Research has shown that the new fluoroscopy system from Omega Medical Imaging significantly reduces radiation exposure. Some studies indicate it can lower radiation by up to 84%. This reduction is crucial because less radiation decreases the risk for patients during procedures.
The FDA has approved the system, confirming it meets safety standards for medical use. Its advanced technology automatically reduces radiation, enhancing safety for both patients and medical staff. So far, the available data has reported no serious side effects.
Patients considering participation in trials involving this technology can find reassurance in these findings. The system appears well-tolerated and prioritizes reducing radiation risks.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it compares a next-generation fluoroscopy system with a conventional one for guiding endoscopic procedures. The next-generation system by Soteria, Omega Medical Imaging, is unique because it promises enhanced imaging capabilities that could improve the precision and safety of these procedures. Unlike conventional systems, this advanced technology might offer clearer images with potentially lower radiation exposure, which is a significant advantage for both patients and healthcare providers. By evaluating these differences, the trial aims to determine if the next-generation system can elevate the standard of care in endoscopic procedures.
What evidence suggests that this trial's fluoroscopy systems could be effective for reducing radiation exposure during endoscopic procedures?
This trial will compare the next-generation fluoroscopy system with the conventional system for endoscopy procedures. Studies have shown that the new fluoroscopy system significantly reduces radiation exposure during these procedures. Known as E-View.AI, this advanced system can lower radiation by up to 84% compared to older methods. It uses AI technology to automatically focus on the needed area, reducing manual adjustments and interruptions. Research indicates that this enhances safety for both patients and medical staff by minimizing unwanted radiation spread. The FDA has approved this system, further confirming its safety and effectiveness.12346
Who Is on the Research Team?
Ji Young Bang
Principal Investigator
Orlando Health
Are You a Good Fit for This Trial?
This trial is for people who need a fluoroscopy-guided endoscopic procedure, such as those with gastrointestinal issues. Participants must be able to safely undergo these procedures and not have any conditions that would make the procedure unsafe.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo fluoroscopy-guided endoscopic procedures using either the next generation or conventional fluoroscopy system
Follow-up
Participants are monitored for safety and effectiveness after the procedure
What Are the Treatments Tested in This Trial?
Interventions
- Next Generation Fluoroscopy System
Trial Overview
The study compares two types of imaging systems used during endoscopy: a next generation fluoroscopy system versus a conventional one. Patients are randomly assigned to either group to see which system reduces radiation exposure more effectively.
How Is the Trial Designed?
2
Treatment groups
Active Control
Patients will undergo fluroscopy-guided endoscopic procedure using the next generation fluoroscopy system (Soteria, Omega Medical Imaging).
Patients will undergo fluroscopy-guided endoscopic procedure using conventional fluoroscopy system (OEC Elite, GE Healthcare).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Orlando Health, Inc.
Lead Sponsor
Citations
X-ray vision in 2025 - PMC - NIH
The ROI technology operates automatically, integrating seamlessly into the clinical workflow without requiring manual adjustments or interrupting the procedure.
Randomized Trial of Next Generation Fluoroscopy System ...
In this randomized trial, we will be comparing radiation exposure between a next generation fluoroscopy system and conventional fluoroscopy ...
3.
omegamedicalimaging.com
omegamedicalimaging.com/mass-gen-provides-safe-high-quality-endoscopy-care-with-omega-fluoro-systems/Mass Gen Provides Safe, High-Quality Endoscopy Care ...
Mass Gen Provides Safe, High-Quality Endoscopy Care with Omega Fluoro Systems · AI detects the doctor's region of interest – allowing for hands- ...
4.
linkedin.com
linkedin.com/posts/omega-medical-imaging_reimagining-fluoroscopy-for-interventional-activity-7376322476055760897-KMVrOmega Medical Imaging develops FDA-cleared ...
- **Guidance**: During the procedure, fluoroscopy (real-time X-ray) or angiography provides a live roadmap for catheter and stent navigation. - ...
5.
omegamedicalimaging.com
omegamedicalimaging.com/fluoro-technology-and-scatter-radiation-in-endoscopy/Fluoro Technology and Scatter Radiation in Endoscopy
As the only lab designed specifically for endoscopic GI procedures, the E-View.AI uses technology to reduce radiation exposure by up to ~84%. In ...
Blog
Interventional fluoroscopy is used in over 10 million procedures annually, making lab teams the most radiation-exposed professionals in medicine ...
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