Stones, KidneyNCT06892626
Flexible Ureteroscopy Versus Percutaneous Nephrolithotomy As Primary Treatment in Renal Stones 2-3 Cm
A study testing RIRS and PNL in people with Stones, Kidney and Stones Ureter, run by Cairo University at 1 site in Egypt.
Trial summary
Flexible Ureteroscopy versus Percutaneous Nephrolithotomy as Primary Treatment in Renal Stones 2-3 Cm Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stones, Kidney, Stones Ureter, Urolithiasis
- What is being tested?
- RIRS and PNL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Aug 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stone burden from 2- 3 cm, single or multiple stones and radio-opaque or radio-lucent stones.
Who cannot join
- stone burden from 2- 3 cm, single or multiple stones and radio-opaque or radio-lucent stones.
Trial locations and contacts
1 site in 1 country.
About this study
Flexible Ureteroscopy versus Percutaneous Nephrolithotomy as Primary Treatment in Renal Stones 2-3 Cm
- Conditions
- Stones, Kidney, Stones Ureter, Urolithiasis
- Being tested
- RIRS, PNL
- Medical subject headings
- Kidney Calculi, Ureterolithiasis, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIRSProcedure or surgery
RIRS performed in lithotomy position for which guide wire pass to the kidney, then passing ureteral dilators up to 14F and ureteral access sheath. Dusting stones by RIRS and holmium laser Fiber 200 mm, at the end of operation DJ was fixed.
PNLProcedure or surgery
PNL performed in prone position, after passing guide wire and ureteric catheter in lithotomy position. Puncture to the kidney, passing 2 wires, then using renal dilators and access sheath to enter kidney by nephroscopy, fragment stones by pneumatic and remove stones, then place nelaton 28F at end of operation
| Study group | Role | What they receive |
|---|---|---|
| RIRS | Experimental | RIRS performed in lithotomy position for which guide wire pass to the kidney, then passing ureteral dilators up to 14F and ureteral access sheath. Dusting stones by RIRS and holmium laser Fiber 200 mm, at the end of operation DJ was fixed. Receives: Procedure: RIRS |
| PNL | Experimental | PNL performed in prone position, after passing guide wire and ureteric catheter in lithotomy position. Puncture to the kidney, passing 2 wires, then using renal dilators and access sheath to enter kidney by nephroscopy, fragment stones by pneumatic and remove stones, then place nelaton 28F at end of operation. Receives: Procedure: PNL |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free rate percentage defined as number of patients who have no stone residual
assessed by Plain urinary tract and ultrasound for confirmation of the presence of residual stone fragments.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start1 Jan 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stones, KidneyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Kamal Torad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892626
- Sponsor's protocol ID
- FURS-PCNL
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexible Ureteroscopy Versus Percutaneous Nephrolithotomy As Primary Treatment in Renal Stones 2-3 Cm
- ClinicalTrials.gov ID
- NCT06892626
- Acronym / sponsor ID
- FURS-PCNL
- Conditions
- Stones, Kidney, Stones Ureter, Urolithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 25 Mar 2025 (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.
Flexible Ureteroscopy versus Percutaneous Nephrolithotomy as Primary Treatment in Renal Stones 2-3 Cm
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIRS | Experimental | Procedure: RIRSRIRS performed in lithotomy position for which guide wire pass to the kidney, then passing ureteral dilators up to 14F and ureteral access sheath. Dusting stones by RIRS and holmium laser Fiber 200 mm, at the end of operation DJ was fixed. |
| PNL | Experimental | Procedure: PNLPNL performed in prone position, after passing guide wire and ureteric catheter in lithotomy position. Puncture to the kidney, passing 2 wires, then using renal dilators and access sheath to enter kidney by nephroscopy, fragment stones by pneumatic and remove stones, then place nelaton 28F at end of operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- stone burden from 2- 3 cm, single or multiple stones and radio-opaque or radio-lucent stones.
Key exclusion criteria (1 listed)
- stone burden from 2- 3 cm, single or multiple stones and radio-opaque or radio-lucent stones.
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 |
|---|---|---|
| RIRSRIRS performed in lithotomy position for which guide wire pass to the kidney, then passing ureteral dilators up to 14F and ureteral access sheath. Dusting stones by RIRS and holmium laser Fiber 200 mm, at the end of operation DJ was fixed. | Procedure or surgery | RIRS |
| PNLPNL performed in prone position, after passing guide wire and ureteric catheter in lithotomy position. Puncture to the kidney, passing 2 wires, then using renal dilators and access sheath to enter kidney by nephroscopy, fragment stones by pneumatic and remove stones, then place nelaton 28F at end of operation | Procedure or surgery | PNL |
Primary outcome
stone free rate percentage defined as number of patients who have no stone residual
Time frame: 18 months
assessed by Plain urinary tract and ultrasound for confirmation of the presence of residual stone fragments.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIRS and PNL in people with Stones, Kidney and Stones Ureter, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stone free rate percentage defined as number of patients who have no stone residual (time frame: 18 months). 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 Mar 2025.