Renal Stone DiseaseNCT07921264
Optimal Intrarenal Pressure During Flexible Ureteroscopy
A study testing FURS with manual irrigation, FURS with automated irrigation (20 mmHg) and FURS with automated irrigation (30 mmHg) in people with Renal Stone Disease, run by Tanta University.
Trial summary
The aim of this work is to determine the effect of different automated intrarenal pressure targets during retrograde intrarenal surgery (RIRS) on intrarenal pressure exposure and to identify the pressure target that provides the optimal balance between pressure control, surgical efficiency, and patient safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Stone Disease
- What is being tested?
- FURS with manual irrigation, FURS with automated irrigation (20 mmHg) and FURS with automated irrigation (30 mmHg)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 31 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 years
- Renal stones 20-30 mm
- Indicated for F-URS
- Pre-stenting
Who cannot join
- Renal stones less than 20 mm
- Pregnancy
- Coagulopathy
- Active UTI
- Ureteral stricture
- Solitary kidney (unless intentionally studying this subgroup)
- Previous urinary diversion
- Congenital anomalies preventing FURS
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Optimal Intrarenal Pressure During Flexible Ureteroscopy: A Randomized Controlled Trial of Pressure-Controlled Irrigation
The aim of this work is to determine the effect of different automated intrarenal pressure targets during retrograde intrarenal surgery (RIRS) on intrarenal pressure exposure and to identify the pressure target that provides the optimal balance between pressure control, surgical efficiency, and patient safety.
This study will compare manual hand-operated irrigation versus automated irrigation with intrarenal pressure targets of 20, 30 and 40 mmHg. The primary endpoint is the time-weighted IRP, and the key secondary endpoint is the postoperative complications.
- Conditions
- Renal Stone Disease
- Being tested
- FURS with manual irrigation, FURS with automated irrigation (20 mmHg), FURS with automated irrigation (30 mmHg), FURS with automated irrigation (40 mmHg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FURS with manual irrigationProcedure or surgery
FURS with manual hand-operated irrigation
FURS with automated irrigation (20 mmHg)Procedure or surgery
FURS with automated Intrarenal pressure target of 20 mmHg
FURS with automated irrigation (30 mmHg)Procedure or surgery
FURS with automated Intrarenal pressure target of 30 mmHg
FURS with automated irrigation (40 mmHg)Procedure or surgery
FURS with automated Intrarenal pressure target of 40 mmHg
| Study group | Role | What they receive |
|---|---|---|
| FURS with manual hand-operated irrigation | Active comparator | Not described Receives: Procedure: FURS with manual irrigation |
| FURS with automated IRP target of 20 mmHg | Experimental | Not described Receives: Procedure: FURS with automated irrigation (20 mmHg) |
| FURS with automated IRP target of 30 mmHg | Experimental | Not described Receives: Procedure: FURS with automated irrigation (30 mmHg) |
| FURS with automated IRP target of 40 mmHg | Experimental | Not described Receives: Procedure: FURS with automated irrigation (40 mmHg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-weighted mean IRP
The average pressure inside the renal collecting system throughout a procedure, accounting for how long each pressure level persists
Measured: Periprocedural
Secondary outcomes (1)
Postoperative infectious complications
Postoperative fever, SIRS or sepsis
Measured: Up to 4 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Stone DiseaseStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Elrefaey, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921264
- Sponsor's protocol ID
- 36265PR225/9/26
- Status last verified
- Nov 2026
- First submitted
- 26 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Intrarenal Pressure During Flexible Ureteroscopy: A Randomized Controlled Trial of Pressure-Controlled Irrigation
- ClinicalTrials.gov ID
- NCT07921264
- Acronym / sponsor ID
- 36265PR225/9/26
- Conditions
- Renal Stone Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 6 Nov 2026 (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.
The aim of this work is to determine the effect of different automated intrarenal pressure targets during retrograde intrarenal surgery (RIRS) on intrarenal pressure exposure and to identify the pressure target that provides the optimal balance between pressure control, surgical efficiency, and patient safety.
This study will compare manual hand-operated irrigation versus automated irrigation with intrarenal pressure targets of 20, 30 and 40 mmHg. The primary endpoint is the time-weighted IRP, and the key secondary endpoint is the postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FURS with manual hand-operated irrigation | Active comparator | Procedure: FURS with manual irrigation |
| FURS with automated IRP target of 20 mmHg | Experimental | Procedure: FURS with automated irrigation (20 mmHg) |
| FURS with automated IRP target of 30 mmHg | Experimental | Procedure: FURS with automated irrigation (30 mmHg) |
| FURS with automated IRP target of 40 mmHg | Experimental | Procedure: FURS with automated irrigation (40 mmHg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Renal stones 20-30 mm
- Indicated for F-URS
- Pre-stenting
Key exclusion criteria (8 listed)
- Renal stones less than 20 mm
- Pregnancy
- Coagulopathy
- Active UTI
- Ureteral stricture
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 |
|---|---|---|
| FURS with manual irrigationFURS with manual hand-operated irrigation | Procedure or surgery | FURS with manual hand-operated irrigation |
| FURS with automated irrigation (20 mmHg)FURS with automated Intrarenal pressure target of 20 mmHg | Procedure or surgery | FURS with automated IRP target of 20 mmHg |
| FURS with automated irrigation (30 mmHg)FURS with automated Intrarenal pressure target of 30 mmHg | Procedure or surgery | FURS with automated IRP target of 30 mmHg |
| FURS with automated irrigation (40 mmHg)FURS with automated Intrarenal pressure target of 40 mmHg | Procedure or surgery | FURS with automated IRP target of 40 mmHg |
Primary outcome
Time-weighted mean IRP
Time frame: Periprocedural
The average pressure inside the renal collecting system throughout a procedure, accounting for how long each pressure level persists
1 secondary outcome
Postoperative infectious complications
Time frame: Up to 4 weeks postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing FURS with manual irrigation, FURS with automated irrigation (20 mmHg) and FURS with automated irrigation (30 mmHg) in people with Renal Stone Disease, run by Tanta University.
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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Elrefaey (+201064831315, mahmoud.elrefaey@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-weighted mean IRP (time frame: Periprocedural). 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 6 Nov 2026.