Reducing Radiation Exposure to Operators During Invasive Cardiac Procedures

NCT ID: NCT03605030

Last Updated: 2018-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-29

Study Completion Date

2018-05-30

Brief Summary

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The primary objective of this study is to determine if a novel lead-based arm board is effective at reducing radiation dose to the operator during invasive cardiac procedures. Secondary objectives are to measure effect on radiation dose to patient and total fluoroscopy (x-ray) time.

Detailed Description

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Conditions

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Patients Undergoing Invasive Cardiac Procedures Radiation Exposure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Novel Lead Based Armboard

Group Type ACTIVE_COMPARATOR

Novel Lead Based Armboard

Intervention Type DEVICE

Novel Lead Based Armboard

Standard Armboard

Group Type PLACEBO_COMPARATOR

Standard Armboard

Intervention Type DEVICE

Standard Armboard (without lead)

Interventions

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Novel Lead Based Armboard

Novel Lead Based Armboard

Intervention Type DEVICE

Standard Armboard

Standard Armboard (without lead)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \> 18
* Planned invasive cardiology procedure, cardiac catheterization with or without percutaneous coronary intervention (PCI), or PCI alone.

Exclusion Criteria

* Inability to provide consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Western University, Canada

OTHER

Sponsor Role collaborator

London Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Pallav Garg

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pallav Garg, MBBS, MSc

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre, Western University, London, ON

Locations

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London Health Sciences Centre

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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108913

Identifier Type: -

Identifier Source: org_study_id

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