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Evaluation of Exposure Reduction Using Region-of-Interest Fluoroscopy (X-ray Fovea Imaging) in Cardiac Interventions

NCT00817115 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2009-08-07

No results posted yet for this study

Summary

The aim of the proposed study is to compare the exposure dose and diagnostic performance of region-of-interest fluoroscopy compared to standard fluoroscopy in patients and interventionists during cardiac interventional procedures. It is hypothesized that systematic application of x-ray attenuation will significantly reduce the radiation exposure of the interventional procedure while maintaining image quality, thereby decreasing risk to the patient.

Conditions

Interventions

DEVICE

Region-of-Interest Imaging (X-ray Fovea Imaging)

Use of an experimental fluoroscopy system fitted with a region-of-interest attenuator (fovea) to evaluate or treat lesions during cardiac interventional procedures.

Sponsors & Collaborators

  • General Electric

    collaborator INDUSTRY

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Alexander J Dick, MD · Sunnybrook Health Sciences Centre

  • Normand Robert, PhD · Sunnybrook Health Sciences Centre

  • John A Rowlands, PhD · Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT00817115 on ClinicalTrials.gov