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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOrlando Health, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Patients undergoing fluoroscopy-guided endoscopic procedure

Physicians and anesthesia staff participating in endoscopic procedures

Disqualifiers

Age < 18 years

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fluoroscopy-guided endoscopic procedure

    Procedure/Surgery

    Patients will be undergoing fluoroscopy-guided endoscopic procedure

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: Next generation fluoroscopy systemActive comparator 1 intervention
Group B: Conventional fluoroscopy systemActive comparator 1 intervention

Trial outcomes

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.

Time frame
1 day

Secondary outcomes

1

Radiation exposure

Compare the level of radiation exposure in patients undergoing fluoroscopy-guided endoscopic procedures between the next generation fluoroscopy system and conventional fluoroscopy system.

Time frame
1 day
2

Total procedure duration

Total duration of fluoroscopy-guided endoscopic procedure

Time frame
1 day
3

Duration of fluoroscopy

Total duration of fluoroscopy usage during the endoscopic procedure

Time frame
1 day

Other outcomes

Sponsors and contacts

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