Renal Stone DiseaseNCT07921251
Automated Versus Manual Irrigation During Flexible Ureteroscopy
A study testing FURS with manual irrigation and FURS with automated irrigation in people with Renal Stone Disease, run by Tanta University.
Trial summary
The Elephant II represents a second-generation flexible and navigable suction UAS. It is available in different calibers and incorporates a flexible distal segment that facilitates navigation with the ureteroscope. 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 and FURS with automated irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 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: Automated Versus Manual Irrigation During Flexible Ureteroscopy: A Randomized Controlled Trial
The Elephant II represents a second-generation flexible and navigable suction UAS. It is available in different calibers and incorporates a flexible distal segment that facilitates navigation with the ureteroscope. Compared with earlier-generation devices, the second-generation Elephant II incorporates a more flexible tip, an improved water-sealing cap, and an enhanced pressure-control module designed to facilitate more consistent suction without requiring continuous manual thumb control.
The development of the Elephant IV represents a further technological evolution toward intelligent pressure-controlled suction during RIRS. Unlike earlier suction-only systems, the newer generation integrates intrarenal pressure monitoring and automated pressure-control mechanisms, allowing irrigation and suction to be dynamically adjusted according to the measured intrarenal pressure. Such an approach may provide a more standardized and physiologically controlled operative environment, potentially avoiding both excessive intrarenal pressure and unnecessarily aggressive suction.
Read more
Therefore, a direct comparison between Elephant II and Elephant IV UASs during RIRS is clinically relevant. Such a study could determine whether the incorporation of real-time intrarenal pressure monitoring and automated pressure regulation translates into measurable improvements in intrarenal pressure control, endoscopic visibility, stone-free rate, irrigation/suction performance, and postoperative infectious and other complications.
The aim of this work is to compare the efficacy and safety of automated intrarenal irrigation during retrograde intrarenal surgery (RIRS) versus the manual hand-operated irrigation.
- Conditions
- Renal Stone Disease
- Being tested
- FURS with manual irrigation, FURS with automated irrigation
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 irrigationProcedure or surgery
FURS with automated pressure-controlled irrigation
| 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 pressure-controlled irrigation | Experimental | Not described Receives: Procedure: FURS with automated irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Stone-free rate (fragments ≤2 mm)
Measured: Up to 4 weeks postoperatively
Secondary outcomes (1)
Postoperative infectious complications (fever, SIRS or sepsis)
Measured: Perioperative/Periprocedural
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
- 200 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
- NCT07921251
- Sponsor's protocol ID
- 36265PR226/9/26
- Status last verified
- Nov 2026
- First submitted
- 29 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
- Automated Versus Manual Irrigation During Flexible Ureteroscopy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07921251
- Acronym / sponsor ID
- 36265PR226/9/26
- Conditions
- Renal Stone Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 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 Elephant II represents a second-generation flexible and navigable suction UAS. It is available in different calibers and incorporates a flexible distal segment that facilitates navigation with the ureteroscope. Compared with earlier-generation devices, the second-generation Elephant II incorporates a more flexible tip, an improved water-sealing cap, and an enhanced pressure-control module designed to facilitate more consistent suction without requiring continuous manual thumb control.
The development of the Elephant IV represents a further technological evolution toward intelligent pressure-controlled suction during RIRS. Unlike earlier suction-only systems, the newer generation integrates intrarenal pressure monitoring and automated pressure-control mechanisms, allowing irrigation and suction to be dynamically adjusted according to the measured intrarenal pressure. Such an approach may provide a more standardized and physiologically controlled operative environment, potentially avoiding both excessive intrarenal pressure and unnecessarily aggressive suction.
Therefore, a direct comparison between Elephant II and Elephant IV UASs during RIRS is clinically relevant. Such a study could determine whether the incorporation of real-time intrarenal pressure monitoring and automated pressure regulation translates into measurable improvements in intrarenal pressure control, endoscopic visibility, stone-free rate, irrigation/suction performance, and postoperative infectious and other complications.
The aim of this work is to compare the efficacy and safety of automated intrarenal irrigation during retrograde intrarenal surgery (RIRS) versus the manual hand-operated irrigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FURS with manual hand-operated irrigation | Active comparator | Procedure: FURS with manual irrigation |
| FURS with automated pressure-controlled irrigation | Experimental | Procedure: FURS with automated irrigation |
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 irrigationFURS with automated pressure-controlled irrigation | Procedure or surgery | FURS with automated pressure-controlled irrigation |
Primary outcome
• Stone-free rate (fragments ≤2 mm)
Time frame: Up to 4 weeks postoperatively
1 secondary outcome
Postoperative infectious complications (fever, SIRS or sepsis)
Time frame: Perioperative/Periprocedural
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 and FURS with automated irrigation 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?
• Stone-free rate (fragments ≤2 mm) (time frame: Up to 4 weeks postoperatively). 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.