Reducing Radiation Exposure to Operators During Invasive... | NCT03605030

Studies
Reducing Radiation Exposure to Operators During Invasive Cardiac Procedures

NCT03605030

Sponsor

London Health Sciences Centre

Status

Completed

Last Update Posted

Jul 30, 2018Actual

Enrollment

360Actual

Phase

Not Applicable

Conditions

Patients Undergoing Invasive Cardiac Procedures
Radiation Exposure

Interventions

Novel Lead Based Armboard
Standard Armboard

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 29, 2017Actual

Primary Completion Date

Jan 25, 2018Actual

Completion Date

May 30, 2018Actual

First Submitted Date

Jul 21, 2018

First Submission Date that Met QC Criteria

Jul 21, 2018

First Posted Date

Jul 30, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2018

Last Update Posted Date

Jul 30, 2018Actual

Name	Class
Western University, Canada	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

360Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Novel Lead Based Armboard	Active Comparator		Device: Novel Lead Based Armboard
Standard Armboard	Placebo Comparator		Device: Standard Armboard

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Novel Lead Based Armboard	Device	Novel Lead Based Armboard	Novel Lead Based Armboard

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radiation dose (μSv) to the operator at the chest	Co-primary outcomes included radiation dose (μSv; mean ± SD) to the operator at the chest and forearm level.	At procedure completion
Radiation dose (μSv) to the operator at the forearm level	Co-primary outcomes included radiation dose (μSv; mean ± SD) to the operator at the chest and forearm level.	At procedure completion

Secondary Outcomes

Measure	Description	Time Frame
Air kerma		At procedure completion
Dose area product		At procedure completion
Radiation dose to the patient

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pallav Garg, MBBS, MSc	London Health Sciences Centre, Western University, London, ON	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
London Health Sciences Centre		London	Ontario		Canada

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided