Recruiting

Next Generation Fluoroscopy vs. Conventional Fluoroscopy

Sponsor:

Orlando Health, Inc.

Code:

NCT07594132

Conditions

Radiation Exposure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fluoroscopy-guided endoscopic procedure

Study Details

Brief 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.

Conditions

Radiation Exposure

Study ID

NCT07594132

Start date

May, 2026

Status verified date

Apr, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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).

Interventions

Fluoroscopy-guided endoscopic procedure

Patients will be undergoing fluoroscopy-guided endoscopic procedure

Primary outcome measure

  • Radiation scatter [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Ji Young Bang

321-842-2273jiyoung.bang@orlandohealth.com

Barbara J Broome

321-841-3742Barbara.Broome@orlandohealth.com

Locations

Orlando Health Digestive Health Institute

Recruiting

Orlando, Florida, United States, 32806

Contacts

Ji Young Bang, MD MPH

321-842-2273jiyoung.bang@orlandohealth.com

Barbara J Broome

321-841-3742barbara.broome@orlandohealth.com

More Information

Sponsor

Orlando Health, Inc.

Last update posted

May 18, 2026

Last verified

Apr, 2026

Keywords

  • Endoscopic ultrasound
  • Endoscopic retrograde cholangiopancreatography
  • Endoscopy
  • Fluoroscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Orlando Health, Inc. on 2026-05-18.