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NCT04404257 · ClinicalTrials.gov registry record · NA

Reduce Radiation Exposure in Fluoroscopic Interventions Evaluation

A NA study of Radiation Exposure and Cardiac Catheterization, sponsored by Corewell Health East.

Completed
Registry status
NA
Development phase
170
Enrollment target
1
Study location

NCT04404257: Completed NA study of Radiation Exposure and Cardiac Catheterization, sponsored by Corewell Health East.

NCT04404257 is a NA study of Radiation Exposure and Cardiac Catheterization that has completed, run by Corewell Health East. The registered enrollment target is 170 participants, above the 26-participant average among 7 other Radiation Exposure trials with a reported enrollment target (554% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04404257, a NA study of Radiation Exposure and Cardiac Catheterization, has completed, sponsored by Corewell Health East.

COMPLETED
Registry status
NA
Development phase
170 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Median effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.

Interventions

  • RADIATION ControlRad System
  • RADIATION Without ControlRad System

Study Locations (1)

Michigan

  • Beaumont Hospital - Royal Oak - Royal Oak

Trial Details

FieldValue
Enrollment Target 170 participants
Start Date 2020-11-05
Est. Completion 2021-12-03
Phase NA
Corewell Health East

106 total trials

What the finished NCT04404257 record still lists

NCT04404257 is an interventional study that assigns participants to a tested intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap, above the 26-participant average among 7 other Radiation Exposure trials with a reported enrollment target (554% higher).

The record links to 2 conditions, with Radiation Exposure appearing as the primary indexed condition, and to 2 interventions - of which ControlRad System is the first listed.

NCT04404257 reports a single indexed study location in Michigan.

Frequently Asked Questions

What is clinical trial NCT04404257 about?

NCT04404257 is a clinical study titled "Reduce Radiation Exposure in Fluoroscopic Interventions Evaluation". 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.

What is the current status of trial NCT04404257?

This trial is currently completed. It is a NA study. The enrollment target is 170 participants. The study started on 2020-11-05. Estimated completion is 2021-12-03.

What conditions does trial NCT04404257 study?

This clinical trial studies the following conditions: Radiation Exposure, Cardiac Catheterization.

What interventions are being tested in trial NCT04404257?

The interventions under investigation include: ControlRad System (RADIATION), Without ControlRad System (RADIATION).

Who is sponsoring clinical trial NCT04404257?

This trial is sponsored by Corewell Health East, which has 106 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04404257 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

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Source: ClinicalTrials.gov NCT04404257, the US trial registry maintained by the National Library of Medicine. NCT04404257 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.