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Reduce Radiation Exposure in Fluoroscopic Interventions Evaluation

NCT04404257 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2023-01-11

Study results available
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Summary

The purpose of this study is to determine whether the ControlRad system device when installed in Fluoroscopic (x-ray) machine reduces radiation dose to operators (Doctors and nurses) and to the patient who is undergoing cardiac Catheterization and electrophysiology (EP) implant procedures.

Conditions

  • Cardiac Catheterization
  • Radiation Exposure

Interventions

RADIATION

ControlRad System

Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.

RADIATION

Without ControlRad System

Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.

Sponsors & Collaborators

  • William Beaumont Hospitals

    lead OTHER

Principal Investigators

  • Simon Dixon, MD · William Beaumont Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-05
Primary Completion
2021-12-03
Completion
2021-12-03
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04404257 on ClinicalTrials.gov