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Status unknownNCT06384105PRDEUpdated Apr 25, 2024

Study of the Patient Radiation Dose During Five Endourological Procedures

An interventional study of frames per second in Radiation Exposure and Urolithiasis, sponsored by Universiteit Antwerpen. Status unknown at 2 sites in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-25.

Sponsored by Universiteit Antwerpen · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Dec 2023, registered Apr 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
870
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Radiation Exposure
  • Urolithiasis

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In context

Urolithiasis

281 studies on the registry are indexed under Urolithiasis; 71 are open to participants now.

This study's planned enrollment of 870 is above the median of 102 across 200 interventional studies indexed under Urolithiasis.

Browse Urolithiasis studies →

Lead sponsor

Universiteit Antwerpen is the lead sponsor of 132 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
870 participants (estimated)

Study arms

  • Experimental
    FPS 3-5

    Frames per second are set at 3-5 at the beginning of the procedure

    Radiation: 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

Interventions

  • Radiationframes per second

    Other settings for frames per second

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What researchers measure

Primary outcomes

  1. Dose limit

    Dose limit for the PRD during the insertion or replacement of a ureteral stent, URS, PCNL and ESWL

    Time frame: 1 year

Secondary outcomes

  1. Difference in PRD

    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

    Time frame: 1 year

  2. PRD different centres

    PRD differ between the different participating urologists and centres

    Time frame: 1 year

  3. PRD difference complicated cases

    PRD difference between normal and complicated cases

    Time frame: 1 year

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Study locations

2 of 2 sites recruiting
  • AZ Klina
    Brasschaat, Antwerp 2930, Belgium
    Recruiting
  • UZA
    Edegem, Antwerp 2650, Belgium
    Recruiting
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References and documents

Study documents

  • Informed consent form · Jul 6, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — All data will be stored in RedCAP and will only be accessible by the principal investigator

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06384105
Responsible party
Vincent De Coninck (Principal Investigator, Universiteit Antwerpen) — Principal investigator
First posted
Apr 25, 2024
Start date
Dec 19, 2023
Primary completion
Dec 18, 2024 (estimated)
Completion
Dec 18, 2024 (estimated)
Last update
Apr 25, 2024

Study contacts

Vincent De Coninck, MD
Contact
vincent.de.coninck@klina.be
+32 3 650 50 56 ext. +32
Stefan De Wachter, MD
Contact
stefan.de.wachter@uza.be
+32 3 821 33 68 ext. +32
Vincent De Coninck, MD
principal investigator · Universiteit Antwerpen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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