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

May 11, 2026 updated by: Orlando Health, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Fluoroscopy is an integral part of both basic and advanced gastrointestinal endoscopy procedures such as stricture dilation, enteral feeding tube placement, double balloon enteroscopy, endoscopic retrograde cholangiopancreatography (ERCP) and interventional endoscopic ultrasound (EUS). Use of fluoroscopy exposes patients, gastroenterologists and endoscopy support personnel to ionizing radiation. While exposure to high-dose-rate ionizing radiation has been shown to be associated with genomic instability, data indicate that exposure to even low-dose radiation, typically utilized for diagnostic imaging, may be associated with an increase in cancer mortality. The lifetime cancer risk is based on the effective dose (ED) of radiation received, which is measured in sieverts (Sv).

In a recent study conducted at a high-volume endoscopy center, the estimated dose equivalent at eye level was estimated to be 126 mSv for an endoscopist performing 500 therapeutic ERCPs per year. Consequently, exposure to ionizing radiation is considered a health hazard to patients as well as gastroenterologists and endoscopy support personnel. As such, appropriate measures to keep radiation exposure as low as reasonably achievable (ALARA) should be implemented. Professional societies such as the American Society for Gastrointestinal Endoscopy (ASGE) and the European Society of Gastrointestinal Endoscopy (ESGE) have published guidelines on radiation safety.

The two main sources of radiation during fluoroscopic procedures are the incident beam, which is the main source of radiation to the patient, and scatter radiation that emanates from the patient's body, which is the main source of radiation to individuals around the patient. Larger the radiation dose to the patient, the greater the scatter. Attempts to minimize radiation exposure include decreasing fluoroscopy time, using pulsed fluoroscopy, increasing the distance from radiation source, shielding, limiting magnification, using collimation, altering x-ray beam angulation, use of artificial intelligence fluoroscopy system, and avoiding use of C-arm units or over-couch x-ray systems. Use of personal protective equipment also reduces occupational exposure; however, many gastroenterologists performing ERCP do not routinely wear optimal protective clothing.

Given the risks of radiation exposure and inherent limitations of the preventive measures outlined, there is a need for additional effective protective methods that are easy to implement. The Soteria E-View system is an FDA-approved, next generation fluoroscopy system that is new to Orlando Health, for use in fluoroscopy-guided endoscopic procedures per standard of care (Omega Medical Imaging, Orlando Florida, USA). The system has been designed to minimize radiation exposure to patients and medical personnel by integrating second-generation artificial intelligence framework (for improved system performance and responsiveness), upgraded C-arm and tables (with enhanced lead flaps along the edges of the table), fluoroless positioning (to reduce reliance on fluoroscopy for positioning steps), reducing frame rate, and robotic system design (to enable automated positioning and movement).

The objective of the study is to compare the radiation exposure and scatter effect between the next generatoin fluoroscopy system and conventional fluoroscopy system during fluoroscopy-guided endoscopic procedures.

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Patients undergoing fluoroscopy-guided endoscopic procedure
  • Physicians and anesthesia staff participating in endoscopic procedures

Exclusion Criteria:

  • Age < 18 years
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Next generation fluoroscopy system
Patients will undergo fluroscopy-guided endoscopic procedure using the next generation fluoroscopy system (Soteria, Omega Medical Imaging).
Procedure: Fluoroscopy-guided endoscopic procedure
Patients will be undergoing fluoroscopy-guided endoscopic procedure
Active Comparator: Conventional fluoroscopy system
Patients will undergo fluroscopy-guided endoscopic procedure using conventional fluoroscopy system (OEC Elite, GE Healthcare).
Procedure: Fluoroscopy-guided endoscopic procedure
Patients will be undergoing fluoroscopy-guided endoscopic procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation scatter
Time Frame: 1 day
Compare the level of radiation scatter during fluoroscopy-guided endoscopic procedures between the next generation fluoroscopy system and conventional fluoroscopy system.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation exposure
Time Frame: 1 day
Compare the level of radiation exposure in patients undergoing fluoroscopy-guided endoscopic procedures between the next generation fluoroscopy system and conventional fluoroscopy system.
1 day
Total procedure duration
Time Frame: 1 day
Total duration of fluoroscopy-guided endoscopic procedure
1 day
Duration of fluoroscopy
Time Frame: 1 day
Total duration of fluoroscopy usage during the endoscopic procedure
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orlando Health, Inc.

Investigators

  • Principal Investigator: Ji Young Bang, Orlando Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

May 11, 2026

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2433321

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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