Renal CalculiNCT07342361
Using Retrograde Intrarenal Surgery for Managing Staghorn Renal Stones.
A study testing Retrograde intrarenal surgery in people with Renal Calculi, run by Helwan University at 1 site in Egypt.
Trial summary
This prospective, randomized study is comparing the safety and efficacy of using two types of ureteral access sheaths in managing staghorn renal stones by retrograde intrarenal surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Renal Calculi
- What is being tested?
- Retrograde intrarenal surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2026to 1 Dec 2026
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients of both sexes.
- Patient has a staghorn renal stone (complete or partial staghorn).
- Normal renal function tests.
- Congenital renal anomalies as horseshoe, pelvic or mal-rotated kidneys.
Who cannot join
- Abnormal coagulation profile.
- Active or untreated urinary tract infection.
- Age under 18 years or above 70 years.
- Patient has a staghorn stone associated with other pathology which requires additional intervention, as ureteral stricture or ureteropelvic junction obstruction (UPJO).
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine, Helwan University
Cairo, 11795
Mohammed H Ali, MD, +20 1005116684, mohamed.soliman@med.helwan.edu.eg
About this study
Official title: Using Bendable Tip-suction Ureteral Access Sheath Compared to Conventional Sheath in Managing Renal Staghorn Stones A Randomized Prospective Study
This prospective, randomized study is comparing the safety and efficacy of using two types of ureteral access sheaths in managing staghorn renal stones by retrograde intrarenal surgery.
Read the detailed description
Staghorn renal calculi is a complex type of renal calculi characterized by their filling of the renal pelvis and branching into all or part of the renal calyces.
Percutaneous nephrolithotomy (PCNL) is currently the recommended primary treatment option for staghorn renal calculi. However, the procedure has significant drawbacks, including invasiveness, postoperative bleeding, infection, prolonged hospitalization, and slow recovery. Retrograde Intrarenal Surgery (RIRS), an effective minimally invasive procedure, has become the first-line treatment for stones smaller than 2cm. With advancements in endoscopic equipment and techniques, RIRS is also being gradually utilized for the treatment of staghorn renal calculi in patients who are not suitable for PCNL.
Ureteral access sheath (UAS) is an important tool for the endourologist. Advantages of using a UAS in ureteroscopy include: ena¬bling repeated passage of the ureteroscope while mini¬mizing damage, improving the flow of irrigation fluid and visualization within the ureter, reducing operative times, reducing the costs of procedures and improving the effectiveness of surgery.
Intending to overcome the shortages of RIRS, a patented ureter access sheath with features of suction and bendable-tip is designed. The tip of the innovated ureteral access sheath can reach the target calyx along with the flexible ureteroscope.
The adjustable continuous negative pressure suction ensures sufficient irrigation speed and maintains a clear surgical field of view, while effectively removing fragmented stones and dust, and reducing the thermal energy generated by laser lithotripsy.
- Conditions
- Renal Calculi
- Being tested
- Retrograde intrarenal surgery
- Keywords
- staghorn calculi, retrograde intrarenal surgery, Ureteral access sheath, Suction
- Medical subject headings
- Kidney Calculi, Staghorn Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde intrarenal surgeryProcedure or surgery
Retrograde intrarenal surgery with using laser for management of renal staghorn stones
| Study group | Role | What they receive |
|---|---|---|
| Group (1): Retrograde intrarenal surgery using a bendable tip-suction ureteral access sheath | Active comparator | During retrograde intrarenal surgery, an ureteral access sheath with bendable tip \& connected to suction system will be used. Receives: Procedure: Retrograde intrarenal surgery |
| Group (2): Retrograde intrarenal surgery using a conventional ureteral access sheath | Placebo comparator | During retrograde intrarenal surgery, a conventional ureteral access sheath will be used. Receives: Procedure: Retrograde intrarenal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the surgical technique
Evaluating and comparing the incidence of operative and postoperative complications
Measured: During surgery to one month after surgery
Secondary outcomes (1)
The efficacy of the surgery
Stone-free rates of the patients will be evaluated by computed tomography after surgery.
Measured: One month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start20 Jan 2026
- Primary completion10 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Renal CalculiStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hassan Ahmed Hassan Elsergany, Helwan University
- Investigators
- Ahmed H Elsergany, MSc, Principal investigator, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342361
- Sponsor's protocol ID
- 129-2025
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bai Y, Wang X, Yang Y, Han P, Wang J. Percutaneous nephrolithotomy versus retrograde intrarenal surgery for the treatment of kidney stones up to 2 cm in patients with solitary kidney: a single centre experience. BMC Urol. 2017 Jan 18;17(1):9. doi: 10.1186/s12894-017-0200-z.
PubMed 28100225Liang H, Liang L, Lin Y, Yu Y, Xu X, Liang Z, Sheng J, Shen B. Application of tip-bendable ureteral access sheath in flexible ureteroscopic lithotripsy: an initial experience of 224 cases. BMC Urol. 2023 Nov 1;23(1):175. doi: 10.1186/s12894-023-01347-x.
PubMed 37915008Kaplan AG, Lipkin ME, Scales CD Jr, Preminger GM. Use of ureteral access sheaths in ureteroscopy. Nat Rev Urol. 2016 Mar;13(3):135-40. doi: 10.1038/nrurol.2015.271. Epub 2015 Nov 24.
PubMed 26597613Zeng G, Zhao Z, Mazzon G, Pearle M, Choong S, Skolarikos A, Denstedt J, Seitz C, Olvera Pasada D, Fiori C, Bosio A, Papatsoris A, Mendez Probst CE, Perez Fentes D, Ann Git K, Wu Q, Wiseman O, Emiliani E, Farahat Y, Ilker Gokce M, Giannakopoulos S, Goumas Kartalas I, Somani B, Knoll T, de la Rosette J, Zhong J, Vinicius Maroccolo M, Saltirov L, Chew B, Wang K, Lahme S, Giusti G, Ferretti S, Yong Cho S, Geavlete P, Cansino R, Kamphuis GM, Smith D, Matlaga BR, Ghani KD, Bernardo N, Silva AD, Ng ACF, Yang S, Gao X, Traxer O, Miernik A, Liatsikos E, Priyakant Parikh K, Duvdevani M, Celia A, Yasui T, Aquino A, Alomar M, Choonhaklai V, Erkurt B, Glass J, Sriprasad S, Osther PJ, Keeley FX Jr, Preminger GM, Cepeda Delgado M, Beltran Suarez E, Ye Z, Sarica K. European Association of Urology Section of Urolithiasis and International Alliance of Urolithiasis Joint Consensus on Retrograde Intrarenal Surgery for the Management of Renal Stones. Eur Urol Focus. 2022 Sep;8(5):1461-1468. doi: 10.1016/j.euf.2021.10.011. Epub 2021 Nov 24.
PubMed 34836838Keller EX, De Coninck V, Doizi S, Traxer O. The role of ureteroscopy for treatment of staghorn calculi: A systematic review. Asian J Urol. 2020 Apr;7(2):110-115. doi: 10.1016/j.ajur.2019.10.012. Epub 2019 Dec 5.
PubMed 32257803
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Bendable Tip-suction Ureteral Access Sheath Compared to Conventional Sheath in Managing Renal Staghorn Stones A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT07342361
- Acronym / sponsor ID
- 129-2025
- Conditions
- Renal Calculi
- Keywords
- staghorn calculi, retrograde intrarenal surgery, Ureteral access sheath, Suction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 15 Jan 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.
This prospective, randomized study is comparing the safety and efficacy of using two types of ureteral access sheaths in managing staghorn renal stones by retrograde intrarenal surgery.
Detailed description
Staghorn renal calculi is a complex type of renal calculi characterized by their filling of the renal pelvis and branching into all or part of the renal calyces.
Percutaneous nephrolithotomy (PCNL) is currently the recommended primary treatment option for staghorn renal calculi. However, the procedure has significant drawbacks, including invasiveness, postoperative bleeding, infection, prolonged hospitalization, and slow recovery. Retrograde Intrarenal Surgery (RIRS), an effective minimally invasive procedure, has become the first-line treatment for stones smaller than 2cm. With advancements in endoscopic equipment and techniques, RIRS is also being gradually utilized for the treatment of staghorn renal calculi in patients who are not suitable for PCNL.
Ureteral access sheath (UAS) is an important tool for the endourologist. Advantages of using a UAS in ureteroscopy include: ena¬bling repeated passage of the ureteroscope while mini¬mizing damage, improving the flow of irrigation fluid and visualization within the ureter, reducing operative times, reducing the costs of procedures and improving the effectiveness of surgery.
Intending to overcome the shortages of RIRS, a patented ureter access sheath with features of suction and bendable-tip is designed. The tip of the innovated ureteral access sheath can reach the target calyx along with the flexible ureteroscope.
The adjustable continuous negative pressure suction ensures sufficient irrigation speed and maintains a clear surgical field of view, while effectively removing fragmented stones and dust, and reducing the thermal energy generated by laser lithotripsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (1): Retrograde intrarenal surgery using a bendable tip-suction ureteral access sheath | Active comparator | Procedure: Retrograde intrarenal surgeryDuring retrograde intrarenal surgery, an ureteral access sheath with bendable tip \& connected to suction system will be used. |
| Group (2): Retrograde intrarenal surgery using a conventional ureteral access sheath | Placebo comparator | Procedure: Retrograde intrarenal surgeryDuring retrograde intrarenal surgery, a conventional ureteral access sheath will be used. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients of both sexes.
- Patient has a staghorn renal stone (complete or partial staghorn).
- Normal renal function tests.
- Congenital renal anomalies as horseshoe, pelvic or mal-rotated kidneys.
Key exclusion criteria (5 listed)
- Abnormal coagulation profile.
- Active or untreated urinary tract infection.
- Age under 18 years or above 70 years.
- Patient has a staghorn stone associated with other pathology which requires additional intervention, as ureteral stricture or ureteropelvic junction obstruction (UPJO).
- Pregnancy.
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 |
|---|---|---|
| Retrograde intrarenal surgeryRetrograde intrarenal surgery with using laser for management of renal staghorn stones | Procedure or surgery | Group (1): Retrograde intrarenal surgery using a bendable tip-suction ureteral access sheath, Group (2): Retrograde intrarenal surgery using a conventional ureteral access sheath |
Primary outcome
Safety of the surgical technique
Time frame: During surgery to one month after surgery
Evaluating and comparing the incidence of operative and postoperative complications
1 secondary outcome
The efficacy of the surgery
Time frame: One month after surgery
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 3 Feb 2026.
- Background: PubMed 28100225Bai Y, Wang X, Yang Y, Han P, Wang J. Percutaneous nephrolithotomy versus retrograde intrarenal surgery for the treatment of kidney stones up to 2 cm in patients with solitary kidney: a single centre experience. BMC Urol. 2017 Jan 18;17(1):9. doi: 10.1186/s12894-017-0200-z.
- Background: PubMed 37915008Liang H, Liang L, Lin Y, Yu Y, Xu X, Liang Z, Sheng J, Shen B. Application of tip-bendable ureteral access sheath in flexible ureteroscopic lithotripsy: an initial experience of 224 cases. BMC Urol. 2023 Nov 1;23(1):175. doi: 10.1186/s12894-023-01347-x.
- Background: PubMed 26597613Kaplan AG, Lipkin ME, Scales CD Jr, Preminger GM. Use of ureteral access sheaths in ureteroscopy. Nat Rev Urol. 2016 Mar;13(3):135-40. doi: 10.1038/nrurol.2015.271. Epub 2015 Nov 24.
- Background: PubMed 34836838Zeng G, Zhao Z, Mazzon G, Pearle M, Choong S, Skolarikos A, Denstedt J, Seitz C, Olvera Pasada D, Fiori C, Bosio A, Papatsoris A, Mendez Probst CE, Perez Fentes D, Ann Git K, Wu Q, Wiseman O, Emiliani E, Farahat Y, Ilker Gokce M, Giannakopoulos S, Goumas Kartalas I, Somani B, Knoll T, de la Rosette J, Zhong J, Vinicius Maroccolo M, Saltirov L, Chew B, Wang K, Lahme S, Giusti G, Ferretti S, Yong Cho S, Geavlete P, Cansino R, Kamphuis GM, Smith D, Matlaga BR, Ghani KD, Bernardo N, Silva AD, Ng ACF, Yang S, Gao X, Traxer O, Miernik A, Liatsikos E, Priyakant Parikh K, Duvdevani M, Celia A, Yasui T, Aquino A, Alomar M, Choonhaklai V, Erkurt B, Glass J, Sriprasad S, Osther PJ, Keeley FX Jr, Preminger GM, Cepeda Delgado M, Beltran Suarez E, Ye Z, Sarica K. European Association of Urology Section of Urolithiasis and International Alliance of Urolithiasis Joint Consensus on Retrograde Intrarenal Surgery for the Management of Renal Stones. Eur Urol Focus. 2022 Sep;8(5):1461-1468. doi: 10.1016/j.euf.2021.10.011. Epub 2021 Nov 24.
- Background: PubMed 32257803Keller EX, De Coninck V, Doizi S, Traxer O. The role of ureteroscopy for treatment of staghorn calculi: A systematic review. Asian J Urol. 2020 Apr;7(2):110-115. doi: 10.1016/j.ajur.2019.10.012. Epub 2019 Dec 5.
- 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.
Ahmed H Elsergany, MSc principal investigator
Helwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retrograde intrarenal surgery in people with Renal Calculi, run by Helwan 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 Feb 2026. 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. Some participants in this study may receive a placebo. 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 Ahmed H Elsergany, MSc. (+20 1151405155, dr_sergany2014@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the surgical technique (time frame: During surgery to one month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07342361, which also lists 5 linked publications.
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 3 Feb 2026.