Study of the Patient Radiation Dose During Five Endourological Procedures (PRDE)

April 22, 2024 updated by: Vincent De Coninck, Universiteit Antwerpen

Prospective Multicentric Study of the Patient Radiation Dose During Five Endourological Procedures: Insertion and Replacement of Ureteral Stent, URS, (Mini-)PCNL/ PCNL and ESWL/SWL

In the medical world more and more procedures are performed with the use of ionizing radiation (x-ray), both diagnostic and therapeutic. The main and most known risk is the development of malignancies as a result of the use of ionizing radiation.

Purpose of this study: To examine the patient radiation dose (PRD) if the frames per second (FPS) are set differently during the five most performed endourological procedures where fluoroscopy is used (insertion/replacement of ureteral stent, (mini-)percutaneous nephrolithotomy (PCNL/PNL), ureterorenoscopy (URS) and extracorporeal shock wave lithotripsy (ESWL/SWL)) and to propose an acceptable PRD for these procedures in a multicentric study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

870

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • Antwerp
      • Brasschaat, Antwerp, Belgium, 2930
      • Edegem, Antwerp, Belgium, 2650

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • all patients who receive insertion/replacement of ureteral stent, URS (flexible or semirigid), (mini-)PCNL (including ECIRS) or ESWL under fluoroscopic with or without ultrasonic guidance
  • Only cases performed or directly supervised by experts

Exclusion Criteria:

  • Bilateral cases
  • Diagnostic ureterorenoscopies
  • Antegrade ureteroscopies
  • Procedures for Upper Tract Urothelial Carcinoma (UTUC)
  • Procedures on children (aged <18 years)
  • Pregnant women
  • Abnormal urinary anatomy (e.g. ureteral duplication, pelvic kidney, bladder derivation, horseshoe kidney)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FPS 3-5
Frames per second are set at 3-5 at the beginning of the procedure
Radiation: frames per second
Other settings for frames per second
Experimental: FPS >5-8
Frames per second are set at >5-8 at the beginning of the procedure
Radiation: frames per second
Other settings for frames per second

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose limit
Time Frame: 1 year
Dose limit for the PRD during the insertion or replacement of a ureteral stent, URS, PCNL and ESWL
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in PRD
Time Frame: 1 year
Difference in the PRD during the insertion or replacement of a ureteral stent, URS, PCNL and ESWL when the FPS are set to 3 to 5 compared to >5 to 8
1 year
PRD different centres
Time Frame: 1 year
PRD differ between the different participating urologists and centres
1 year
PRD difference complicated cases
Time Frame: 1 year
PRD difference between normal and complicated cases
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiteit Antwerpen

Investigators

  • Principal Investigator: Vincent De Coninck, MD, Universiteit Antwerpen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2023

Primary Completion (Estimated)

December 18, 2024

Study Completion (Estimated)

December 18, 2024

Study Registration Dates

First Submitted

April 1, 2024

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRDE1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All data will be stored in RedCAP and will only be accessible by the principal investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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