NCT07594132

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
22mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
May 2026Apr 2028

Study Start

First participant enrolled

May 1, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

May 18, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

May 11, 2026

Last Update Submit

May 11, 2026

Conditions

Radiation Exposure

Keywords

Endoscopic ultrasoundEndoscopic retrograde cholangiopancreatographyEndoscopyFluoroscopy

Outcome Measures

Primary Outcomes (1)

  • Radiation scatter

    Compare the level of radiation scatter during fluoroscopy-guided endoscopic procedures between the next generation fluoroscopy system and conventional fluoroscopy system.

    1 day

Secondary Outcomes (3)

  • Radiation exposure

    1 day

  • Total procedure duration

    1 day

  • Duration of fluoroscopy

    1 day

Study Arms (2)

Next generation fluoroscopy system

ACTIVE COMPARATOR

Patients will undergo fluroscopy-guided endoscopic procedure using the next generation fluoroscopy system (Soteria, Omega Medical Imaging).

Procedure: Fluoroscopy-guided endoscopic procedure

Conventional fluoroscopy system

ACTIVE COMPARATOR

Patients will undergo fluroscopy-guided endoscopic procedure using conventional fluoroscopy system (OEC Elite, GE Healthcare).

Procedure: Fluoroscopy-guided endoscopic procedure

Interventions

Fluoroscopy-guided endoscopic procedurePROCEDURE

Patients will be undergoing fluoroscopy-guided endoscopic procedure

Conventional fluoroscopy systemNext generation fluoroscopy system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Age \< 18 years
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orlando Health Digestive Health Institute

Orlando, Florida, 32806, United States

RECRUITING

Study Officials

  • Ji Young Bang

    Orlando Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ji Young Bang

CONTACT

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

Barbara J Broome

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2026

First Posted

May 18, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

April 1, 2028

Last Updated

May 18, 2026

Record last verified: 2026-04

Locations

US(1)