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

Part of paid clinical trials in Orlando, Florida.

Sponsor
Orlando Health, Inc.
Study ID
NCT07594132
Status
Recruiting
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Conditions

  • Radiation Exposure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fluoroscopy-guided endoscopic procedure — PROCEDURE
    Patients will be undergoing fluoroscopy-guided endoscopic procedure

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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).

Primary Outcome Measure

Radiation scatter [ Time Frame: 1 day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Orlando Health Digestive Health InstituteOrlandoFlorida32806
Ji Young Bang, MD MPH
[email protected]
321-842-2273
Barbara J Broome
[email protected]
321-841-3742

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Orlando Health Digestive Health Institute· Orlando, FL

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