CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 170 enrolled
Drug / intervention
ControlRad System +1 moreradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04404257
NCT04404257N/ACompleted
CompareCT.gov

Reduce Radiation Exposure in Fluoroscopic Interventions Evaluation (REDEFINE): A Prospective, Randomized Evaluation of the ControlRad System to Reduce Radiation Exposure During Cardiac Catheterization and Electrophysiology (EP) Procedures.

Corewell Health East·interventional·Posted May 27, 2020·Updated Jan 11, 2023

In Brief

A clinical study evaluating ControlRad System and Without ControlRad System for Cardiac Catheterization and Radiation Exposure. Completed, enrolled 170 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Catheterization, Radiation Exposure
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMay 27, 2020
Enrollment StartNov 5, 2020
Primary CompletionDec 3, 2021
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 6.1 years ago

Interventions

ControlRad Systemradiation

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

Without ControlRad Systemradiation

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