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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04285944
Other study ID # S62469
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date May 31, 2020

Study information

Verified date March 2020
Source Universitaire Ziekenhuizen Leuven
Contact Sabine Van Roey
Phone 003216342465
Email sabine.vanroey@uzleuven.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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®.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date May 31, 2020
Est. primary completion date May 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Patient undergoing the procedure is older than 18 years and is planned for a coronary angiogram, cardiac catheterization and/or percutaneous coronary intervention.

2. The coronary angiogram/cardiac catheterization/PCI procedure is elective.

3. 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. -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mavig X-ray Protective Drapes
Mavig X-ray Protective Drapes®

Locations

Country Name City State
Belgium Department of Cardiovascular Disease, University Hospitals Leuven Leuven
Belgium UZ Leuven Leuven

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Operator radiation dose Gray Immediate
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