NCT04078165

Brief Summary

This trial investigates operator radiation doses when performing standardized procedures using two different means of radiation protection, namely conventional lead shield and apron versus suspended protection system (Zero-Gravity, ZG). The performed procedure is standard endovascular aortic repair (EVAR). The hypothesis is that ZG offers superior protection for the operator.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

September 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 4, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

May 13, 2021

Status Verified

May 1, 2021

Enrollment Period

1.6 years

First QC Date

August 30, 2019

Last Update Submit

May 12, 2021

Conditions

Radiation Exposure

Keywords

radiation protectionEVARendovascular surgery

Outcome Measures

Primary Outcomes (1)

  • Radiation exposure

    Radiation dosages in multiple dosimeters on operator

    During operations

Secondary Outcomes (3)

  • Fluoroscopy duration

    During operation

  • Fluoroscopy dose area product (DAP)

    During operation

  • Entrance skin air KERMA

    During operation

Study Arms (2)

Zero-Gravity

EXPERIMENTAL

In this group, the operator uses the Zero-Gravity protection system

Device: Zero-Gravity

Conventional

ACTIVE COMPARATOR

In this group, the operator uses conventional radiation protection

Device: Conventional radiation protection

Interventions

Zero-GravityDEVICE

Free-floating, suspended personal radiation protection

Zero-Gravity
Conventional radiation protectionDEVICE

Standard lead shields and aprons

Conventional

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all patients eligible for standard EVAR at Helsinki University Hospital

You may not qualify if:

  • any additional interventions such as embolization, recanalization, screw fixation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Hospital

Helsinki, Finland

Location

Related Publications (1)

  • Serna Santos J, Kaasalainen T, Laukontaus S, Bjorkman P, Heinola I, Laine M, Vikatmaa P, Pekkarinen A, Venermo M, Aho P. The Effect of a Suspended Radiation Protection System on Occupational Radiation Doses During Infrarenal EVAR Procedures: A Randomised Controlled Study. Eur J Vasc Endovasc Surg. 2024 Mar;67(3):435-443. doi: 10.1016/j.ejvs.2023.08.039. Epub 2023 Aug 22.

    PMID: 37611731DERIVED

Study Officials

  • Maarit Venermo, MD, PhD

    University of Helsinki

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 30, 2019

First Posted

September 4, 2019

Study Start

September 2, 2019

Primary Completion

March 31, 2021

Study Completion

April 30, 2021

Last Updated

May 13, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)