Operator Radiation Protection During Cardiac Catheterizat... | NCT04285944

Studies
Operator Radiation Protection During Cardiac Catheterization Using Mavig X-ray Protective Drapes®.

NCT04285944

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Unknown status

Last Update Posted

Mar 4, 2020Actual

Enrollment

1,000Estimated

Phase

Not Applicable

Conditions

Radiation Exposure

Interventions

Mavig X-ray Protective Drapes

Countries

Belgium

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

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2019Actual

Primary Completion Date

May 31, 2020Estimated

Completion Date

May 31, 2020Estimated

First Submitted Date

Feb 24, 2020

First Submission Date that Met QC Criteria

Feb 24, 2020

First Posted Date

Feb 26, 2020Actual

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

Mar 2, 2020

Last Update Posted Date

Mar 4, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof Dr Walter Desmet, Professor, Universitaire Ziekenhuizen KU LeuvenPrincipal Investigator

Lead Sponsor

Universitaire Ziekenhuizen KU LeuvenOTHER

Collaborators

Not provided

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

Interventional cardiologists are exposed to significant doses of scatter radiation during cardiac catheterization and percutaneous coronary intervention. Traditional methods of reducing the radiation dose for operators in the cardiac catheterization laboratory include limiting the use of radiation, radiation protection aprons and shields, and the use of lead eye glasses. Despite these measures several parts of the operators body, including the head and neck, are poorly screened from scatter radiation. Radiation protection drapes have been developed for use in cardiac catheterization but no randomized controlled study has yet been performed with the commercially available Mavig X-ray Protective Drapes®. The aim of this study is to evaluate operator radiation protection using Mavig X-ray Protective Drapes®.

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

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study	Active Comparator		Other: Mavig X-ray Protective Drapes
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mavig X-ray Protective Drapes	Other	Mavig X-ray Protective Drapes®	Study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Operator radiation dose	Gray	Immediate

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient undergoing the procedure is older than 18 years and is planned for a coronary angiogram, cardiac catheterization and/or percutaneous coronary intervention.
The coronary angiogram/cardiac catheterization/PCI procedure is elective.
The patient undergoing the procedure is male, or if female, has no childbearing potential or is not pregnant.

Exclusion Criteria:

1. The procedure is an emergency and/or the patient is unstable. -

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

Name	Role	Phone	Extension	Email
Sabine Van Roey	Contact	003216342465	+32468312267	sabine.vanroey@uzleuven.be
Keir Mccutcheon	Contact	+32468312267	+32468312267	keir.mccutcheon@uzleuven.be

Overall Officials

Name	Affiliation	Role
Keir Mccutcheon	Universitaire Ziekenhuizen KU Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardiovascular Disease, University Hospitals Leuven	Recruiting	Leuven		3000	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34987314	Derived	McCutcheon K, Vanhaverbeke M, Dabin J, Pauwels R, Schoonjans W, Desmet W, Bennett J. Efficacy of MAVIG X-Ray Protective Drapes in Reducing CTO Operator Radiation. J Interv Cardiol. 2021 Dec 14;2021:3146104. doi: 10.1155/2021/3146104. eCollection 2021.
33092401	Derived	McCutcheon K, Vanhaverbeke M, Pauwels R, Dabin J, Schoonjans W, Bennett J, Adriaenssens T, Dubois C, Sinnaeve P, Desmet W. Efficacy of MAVIG X-Ray Protective Drapes in Reducing Operator Radiation Dose in the Cardiac Catheterization Laboratory: A Randomized Controlled Trial. Circ Cardiovasc Interv. 2020 Nov;13(11):e009627. doi: 10.1161/CIRCINTERVENTIONS.120.009627. Epub 2020 Oct 23.