Radiation ExposurePRDENCT06384105
Study of the Patient Radiation Dose During Five Endourological Procedures
A study testing frames per second in people with Radiation Exposure and Urolithiasis, run by Universiteit Antwerpen at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Radiation Exposure, Urolithiasis
- What is being tested?
- frames per second
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 870 participants
- Where
- 2 sitesBelgium
- Study dates
- 19 Dec 2023to 18 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Recruiting
AZ Klina
Brasschaat, Antwerp, 2930
Vincent De Coninck, MD, +32 3 650 50 56 ext. +32, vincent.de.coninck@klina.be
- Recruiting
UZA
Edegem, Antwerp, 2650
Stefan De Wachter, MD, +32 3 821 33 68 ext. +32, stefan.de.wachter@uza.be
About this study
Official title: 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.
- Conditions
- Radiation Exposure, Urolithiasis
- Being tested
- frames per second
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
frames per secondRadiation
Other settings for frames per second
| Study group | Role | What they receive |
|---|---|---|
| FPS 3-5 | Experimental | Frames per second are set at 3-5 at the beginning of the procedure Receives: Radiation: frames per second |
| FPS >5-8 | Experimental | Frames per second are set at >5-8 at the beginning of the procedure Receives: Radiation: frames per second |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limit
Dose limit for the PRD during the insertion or replacement of a ureteral stent, URS, PCNL and ESWL
Measured: 1 year
Secondary outcomes (3)
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
Measured: 1 year
PRD different centres
PRD differ between the different participating urologists and centres
Measured: 1 year
PRD difference complicated cases
PRD difference between normal and complicated cases
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start19 Dec 2023
- Primary completion18 Dec 2024 (estimated)
- Study completion18 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 870 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincent De Coninck, Universiteit Antwerpen
- Investigators
- Vincent De Coninck, MD, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384105
- Sponsor's protocol ID
- PRDE1
- Acronym
- PRDE
- Status last verified
- Apr 2024
- First submitted
- 1 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be stored in RedCAP and will only be accessible by the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06384105
- Acronym / sponsor ID
- PRDE / PRDE1
- Conditions
- Radiation Exposure, Urolithiasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 870 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 18 Dec 2024 (estimated)
- Study completion
- 18 Dec 2024 (estimated)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FPS 3-5 | Experimental | Radiation: frames per secondFrames per second are set at 3-5 at the beginning of the procedure |
| FPS >5-8 | Experimental | Radiation: frames per secondFrames per second are set at >5-8 at the beginning of the procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- Bilateral cases
- Diagnostic ureterorenoscopies
- Antegrade ureteroscopies
- Procedures for Upper Tract Urothelial Carcinoma (UTUC)
- Procedures on children (aged <18 years)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| frames per secondOther settings for frames per second | Radiation | FPS 3-5, FPS >5-8 |
Primary outcome
Dose limit
Time frame: 1 year
Dose limit for the PRD during the insertion or replacement of a ureteral stent, URS, PCNL and ESWL
3 secondary outcomes
Difference in PRD
Time frame: 1 year
PRD different centres
Time frame: 1 year
PRD difference complicated cases
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: No. All data will be stored in RedCAP and will only be accessible by the principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent De Coninck, MD principal investigator
Universiteit Antwerpen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing frames per second in people with Radiation Exposure and Urolithiasis, run by Universiteit Antwerpen at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent De Coninck, MD (+32 3 650 50 56 ext. +32, vincent.de.coninck@klina.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limit (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.