Stone;Renalmini-PCNL/FANSNCT07306819
Comparison Between Two Methods for Renal Stone Treatment Mini Percutaneous Nephrolithotomy and Flexible Ureteroscopy With Suction Sheath
A study testing mini-percutaneous nephrolithotomy and Flexible Uerteroscopy with Tip-Bendable Suction Sheath in people with Stone;Renal and Stone, Urinary, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to compare the efficacy and safety of two modern, minimally invasive surgical techniques for the removal of kidney stones: Mini-Percutaneous Nephrolithotomy (Mini-PCNL) and Flexible Ureteroscopy (FURS) with Flexible and navigable suction sheath The primary objective is to determine which procedure… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stone;Renal, Stone, Urinary, Stone, Kidney
- What is being tested?
- mini-percutaneous nephrolithotomy and Flexible Uerteroscopy with Tip-Bendable Suction Sheath
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2025to 15 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aging 18 years old or more.
- Patients with renal stones between 2-3 cm in size confirmed by CT scan.
Who cannot join
- Patients with previous ureteric injury.
- Patients with uncontrolled diabetes mellitus or hypertension.
- Patients with uncontrolled hepatic dysfunction.
- Patients with uremia or renal failure.
- Pregnant patients.
- patients with active urinary tract infection.
- Patients with bleeding tendency or uncontrolled coagulopathy.
- Patients with congenital anomalies as horse-shoe kidney and pelvi-ureteric junction obstruction.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ahmed Higazy, Lecturer of Urology contact
About this study
Official title: Flexible Ureteroscopy Using a Tip-Bendable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for the Treatment of 2-3 cm Renal Stones: A Randomized Controlled Trial
This study aims to compare the efficacy and safety of two modern, minimally invasive surgical techniques for the removal of kidney stones: Mini-Percutaneous Nephrolithotomy (Mini-PCNL) and Flexible Ureteroscopy (FURS) with Flexible and navigable suction sheath
The primary objective is to determine which procedure results in a higher stone-free rate, as measured by post-operative imaging. Secondary objectives include comparing operative time, hospitalization length andcomplication rates between the two treatment groups.
Patients with two to three centimeter kidney stones who are candidates for either procedure will be randomly assigned to undergo either Mini-PCNL or suctioning FURS. The outcomes will be critically assessed to help establish a higher level of evidence for guiding surgical management of kidney stones.
Read the detailed description
Mini-PCNL involves creating a small tract from the skin on the back directly into the kidney, through which a miniature nephroscope is passed to visualize and remove stones. Flexible Ureteroscopy is performed by passing a thin, flexible scope through the natural urinary passage (urethra and ureter) into the kidney. The specific FURS technique in this study utilizes a specialized scope with integrated suction, which is theorized to improve stone fragment clearance.
- Conditions
- Stone;Renal, Stone, Urinary, Stone, Kidney, Stone Clearance
- Being tested
- mini-percutaneous nephrolithotomy, Flexible Uerteroscopy with Tip-Bendable Suction Sheath
- Medical subject headings
- Nephrolithiasis, Urinary Calculi, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mini-percutaneous nephrolithotomyProcedure or surgery
Also called Mini-PCNL, mPCNL
Under general anesthesia, a 6 Fr ureteral catheter will be placed into the target ureter via cystoscopy, and bladder drainage will be achieved with a 16 Fr Foley catheter. The patient will then be repositioned to the prone position. Percutaneous renal access will be obtained by puncturing the selected calyx with an 18-gauge coaxial needle under fluoroscopic or ultrasound guidance. Tract dilation will be performed using fascial dilators up to 20 Fr then the mini-PCNL sheath (mini-Amplatz sheath) will be inserted and the mini nephroscope 12 to 15 Fr will be used. If multiple nephrostomy tracts are required for stone removal, the same approach will be repeated for each tract. Stone fragmentation will be carried out with a pneumatic lithotripter.
At the end of the procedure, a 6 Fr double-J ureteral stent will be inserted for 4 weeks, and whether to place a nephrostomy tube will be determined at the discretion of the operating surgeon.
Flexible Uerteroscopy with Tip-Bendable Suction SheathProcedure or surgery
Also called FANS, FURS with Suction Sheath
under general anesthesia with the patient in the lithotomy position. A 6 Fr ureteral catheter will first be placed into the ureter, followed by retrograde pyelography to assess the upper urinary tract. A guidewire will then be advanced into the renal pelvis. either a 12/14 Fr or 11/13 Fr tip-bendable S-UAS will be inserted. If insertion is not possible due to ureteral narrowing, a smaller 10/12 Fr UAS will be attempted. if failed, a double-J stent will be placed and the procedure terminated, with a second session scheduled 4 weeks later. fURS will be performed using digital flexible ureteroscopes either 8.5 Fr or 7.5 Fr according to UAS size; an 8.5-Fr scope for a 12/14 Fr UAS, and a 7.5-Fr scope for an 11/13-Fr or 10/12-Fr UAS. Stone fragmentation will be performed using a holmium laser (Ho: YAG) with a 272-μm fiber and an energy setting below 30 W. Irrigation will be maintained at 50-100 ml/min and suction pressure at 80-120 mmHg. at the end a 6 Fr JJ will be inserted for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| mini-PCNL | Experimental | Under general anesthesia, a 6 Fr ureteral catheter will be placed into the target ureter via cystoscopy, and bladder drainage will be achieved with a 16 Fr Foley catheter. The patient will then be repositioned to the prone position. Percutaneous renal access will be obtained by puncturing the selected calyx with an 18-gauge coaxial needle under fluoroscopic or ultrasound guidance. Tract dilation will be performed using fascial dilators up to 20 Fr then the mini-PCNL sheath (mini-Amplatz sheath) will be inserted and the mini nephroscope 12 to 15 Fr will be used. If multiple nephrostomy tracts are required for stone removal, the same approach will be repeated for each tract. Stone fragmentation will be carried out with a pneumatic lithotripter.
At the end of the procedure, a 6 Fr double-J ureteral stent will be inserted for 4 weeks, and whether to place a nephrostomy tube will be determined at the discretion of the operating surgeon. Receives: Procedure: mini-percutaneous nephrolithotomy |
| FURS with Tip-Bendable Suction Sheath | Experimental | under general anesthesia with the patient in the lithotomy position. A 6 Fr ureteral catheter will first be placed into the ureter, followed by retrograde pyelography to assess the upper urinary tract. A guidewire will then be advanced into the renal pelvis. either a 12/14 Fr or 11/13 Fr tip-bendable S-UAS will be inserted. If insertion is not possible due to ureteral narrowing, a smaller 10/12 Fr UAS will be attempted. if failed, a double-J stent will be placed and the procedure terminated, with a second session scheduled 4 weeks later. fURS will be performed using digital flexible ureteroscopes either 8.5 Fr or 7.5 Fr according to UAS size; an 8.5-Fr scope for a 12/14 Fr UAS, and a 7.5-Fr scope for an 11/13-Fr or 10/12-Fr UAS. Stone fragmentation will be performed using a holmium laser (Ho: YAG) with a 272-μm fiber and an energy setting below 30 W. Irrigation will be maintained at 50-100 ml/min and suction pressure at 80-120 mmHg. at the end a 6 Fr JJ will be inserted for 4 weeks. Receives: Procedure: Flexible Uerteroscopy with Tip-Bendable Suction Sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free rate
The proportion of participants in each treatment arm who are completely free of any stone fragments in the treated kidney, following the initial procedure and without the need for any secondary surgical interventions. Status will be determined by a blinded central radiologist.
Measured: one month postoperative
Secondary outcomes (2)
length of hospital stay
The total duration of inpatient hospitalization following the procedure, calculated from the day of surgery to the day of discharge
Measured: From date of surgery until date of hospital discharge for 14 days (measured in days).
operative time
The total time from the initiation of the procedure to the final removal of all endoscopic equipment and placement/completion of any necessary stents
Measured: Measured intraoperatively, from procedure start to end (in minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start15 Oct 2025
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Stone;RenalStudies 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
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed M Hasab Allah, Ahmed Maher Teaching Hospital
- Investigators
- Ahmed M Tawfeek, assistant proffessor, Study chair, Ain Shams University, Department Of UrologyAhmed Higazy, lecturer of urology, Study director, Ain Shams University, Department Of UrologyAshraf Satour, lecturer of urology, Study director, Ain Shams University, Department Of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306819
- Sponsor's protocol ID
- FMASU MS 725/2025
- Acronym
- mini-PCNL/FANS
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu W, Liu S, Cao J, Wang H, Liang H, Jiang K, Cui Y, Chai CA, Sahinler EB, Aquino A, Mazzon G, Zhong W, Zhao Z, Zhang L, Ding J, Wang Q, Wang Y, Chen KW, Liu Y, Choong S, Sarica K, Zeng G. Tip bendable suction ureteral access sheath versus traditional sheath in retrograde intrarenal stone surgery: an international multicentre, randomized, parallel group, superiority study. EClinicalMedicine. 2024 Jul 5;74:102724. doi: 10.1016/j.eclinm.2024.102724. eCollection 2024 Aug.
PubMed 39070176Tang QL, Liang P, Ding YF, Zhou XZ, Tao RZ. Comparative efficacy between retrograde intrarenal surgery with vacuum-assisted ureteral access sheath and minimally invasive percutaneous nephrolithotomy for 1-2 cm infectious upper ureteral stones: a prospective, randomized controlled study. Front Surg. 2023 Jul 7;10:1200717. doi: 10.3389/fsurg.2023.1200717. eCollection 2023.
PubMed 37483661Skolarikos A, Jung H, Neisius A, et al. EAU guidelines on urolithiasis. Arnhem, Netherlands: European Association of Urology; 2024.
Pauchard F, Ventimiglia E, Corrales M, Traxer O. A Practical Guide for Intra-Renal Temperature and Pressure Management during Rirs: What Is the Evidence Telling Us. J Clin Med. 2022 Jun 15;11(12):3429. doi: 10.3390/jcm11123429.
PubMed 35743499Guven S, Yigit P, Tuncel A, Karabulut I, Sahin S, Kilic O, Balasar M, Seckiner I, Canda E, Sonmez MG, Tefik T, Boz MY, Atis G, Ergin G, Soytas M, Senel C, Kirac M, Kiremit MC, Akand M, Tugcu V, Erkurt B, Muslumanoglu A, Sarica K. Retrograde intrarenal surgery of renal stones: a critical multi-aspect evaluation of the outcomes by the Turkish Academy of Urology Prospective Study Group (ACUP Study). World J Urol. 2021 Feb;39(2):549-554. doi: 10.1007/s00345-020-03210-2. Epub 2020 Apr 28.
PubMed 32347334Geraghty R, Abourmarzouk O, Rai B, Biyani CS, Rukin NJ, Somani BK. Evidence for Ureterorenoscopy and Laser Fragmentation (URSL) for Large Renal Stones in the Modern Era. Curr Urol Rep. 2015 Aug;16(8):54. doi: 10.1007/s11934-015-0529-3.
PubMed 26077357Gauhar V, Traxer O, Castellani D, Sietz C, Chew BH, Fong KY, Hamri SB, Gokce MI, Gadzhiev N, Galosi AB, Yuen SKK, El Hajj A, Ko R, Zawadzki M, Sridharan V, Lakmichi MA, Corrales M, Malkhasyan V, Ragoori D, Soebhali B, Tan K, Chai CA, Tursunkulov AN, Tanidir Y, Persaud S, Elshazly M, Kamal W, Tefik T, Shrestha A, Tiong HC, Somani BK. Could Use of a Flexible and Navigable Suction Ureteral Access Sheath Be a Potential Game-changer in Retrograde Intrarenal Surgery? Outcomes at 30 Days from a Large, Prospective, Multicenter, Real-world Study by the European Association of Urology Urolithiasis Section. Eur Urol Focus. 2024 Dec;10(6):975-982. doi: 10.1016/j.euf.2024.05.010. Epub 2024 May 24.
PubMed 38789313Alenezi H, Denstedt JD. Flexible ureteroscopy: Technological advancements, current indications and outcomes in the treatment of urolithiasis. Asian J Urol. 2015 Jul;2(3):133-141. doi: 10.1016/j.ajur.2015.06.002. Epub 2015 Jun 23.
PubMed 29264133
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexible Ureteroscopy Using a Tip-Bendable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for the Treatment of 2-3 cm Renal Stones: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07306819
- Acronym / sponsor ID
- mini-PCNL/FANS / FMASU MS 725/2025
- Conditions
- Stone;Renal, Stone, Urinary, Stone, Kidney, Stone Clearance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 29 Dec 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.
This study aims to compare the efficacy and safety of two modern, minimally invasive surgical techniques for the removal of kidney stones: Mini-Percutaneous Nephrolithotomy (Mini-PCNL) and Flexible Ureteroscopy (FURS) with Flexible and navigable suction sheath
The primary objective is to determine which procedure results in a higher stone-free rate, as measured by post-operative imaging. Secondary objectives include comparing operative time, hospitalization length andcomplication rates between the two treatment groups.
Patients with two to three centimeter kidney stones who are candidates for either procedure will be randomly assigned to undergo either Mini-PCNL or suctioning FURS. The outcomes will be critically assessed to help establish a higher level of evidence for guiding surgical management of kidney stones.
Detailed description
Mini-PCNL involves creating a small tract from the skin on the back directly into the kidney, through which a miniature nephroscope is passed to visualize and remove stones. Flexible Ureteroscopy is performed by passing a thin, flexible scope through the natural urinary passage (urethra and ureter) into the kidney. The specific FURS technique in this study utilizes a specialized scope with integrated suction, which is theorized to improve stone fragment clearance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mini-PCNL | Experimental | Procedure: mini-percutaneous nephrolithotomyUnder general anesthesia, a 6 Fr ureteral catheter will be placed into the target ureter via cystoscopy, and bladder drainage will be achieved with a 16 Fr Foley catheter. The patient will then be repositioned to the prone position. Percutaneous renal access will be obtained by puncturing the selected calyx with an 18-gauge coaxial needle under fluoroscopic or ultrasound guidance. Tract dilation will be performed using fascial dilators up to 20 Fr then the mini-PCNL sheath (mini-Amplatz sheath) will be inserted and the mini nephroscope 12 to 15 Fr will be used. If multiple nephrostomy tracts are required for stone removal, the same approach will be repeated for each tract. Stone fragmentation will be carried out with a pneumatic lithotripter. At the end of the procedure, a 6 Fr double-J ureteral stent will be inserted for 4 weeks, and whether to place a nephrostomy tube will be determined at the discretion of the operating surgeon. |
| FURS with Tip-Bendable Suction Sheath | Experimental | Procedure: Flexible Uerteroscopy with Tip-Bendable Suction Sheathunder general anesthesia with the patient in the lithotomy position. A 6 Fr ureteral catheter will first be placed into the ureter, followed by retrograde pyelography to assess the upper urinary tract. A guidewire will then be advanced into the renal pelvis. either a 12/14 Fr or 11/13 Fr tip-bendable S-UAS will be inserted. If insertion is not possible due to ureteral narrowing, a smaller 10/12 Fr UAS will be attempted. if failed, a double-J stent will be placed and the procedure terminated, with a second session scheduled 4 weeks later. fURS will be performed using digital flexible ureteroscopes either 8.5 Fr or 7.5 Fr according to UAS size; an 8.5-Fr scope for a 12/14 Fr UAS, and a 7.5-Fr scope for an 11/13-Fr or 10/12-Fr UAS. Stone fragmentation will be performed using a holmium laser (Ho: YAG) with a 272-μm fiber and an energy setting below 30 W. Irrigation will be maintained at 50-100 ml/min and suction pressure at 80-120 mmHg. at the end a 6 Fr JJ will be inserted for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients aging 18 years old or more.
- Patients with renal stones between 2-3 cm in size confirmed by CT scan.
Key exclusion criteria (8 listed)
- Patients with previous ureteric injury.
- Patients with uncontrolled diabetes mellitus or hypertension.
- Patients with uncontrolled hepatic dysfunction.
- Patients with uremia or renal failure.
- Pregnant patients.
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 |
|---|---|---|
| mini-percutaneous nephrolithotomyAlso: Mini-PCNL, mPCNLUnder general anesthesia, a 6 Fr ureteral catheter will be placed into the target ureter via cystoscopy, and bladder drainage will be achieved with a 16 Fr Foley catheter. The patient will then be repositioned to the prone position. Percutaneous renal access will be obtained by puncturing the selected calyx with an 18-gauge coaxial needle under fluoroscopic or ultrasound guidance. Tract dilation will be performed using fascial dilators up to 20 Fr then the mini-PCNL sheath (mini-Amplatz sheath) will be inserted and the mini nephroscope 12 to 15 Fr will be used. If multiple nephrostomy tracts are required for stone removal, the same approach will be repeated for each tract. Stone fragmentation will be carried out with a pneumatic lithotripter. At the end of the procedure, a 6 Fr double-J ureteral stent will be inserted for 4 weeks, and whether to place a nephrostomy tube will be determined at the discretion of the operating surgeon. | Procedure or surgery | mini-PCNL |
| Flexible Uerteroscopy with Tip-Bendable Suction SheathAlso: FANS, FURS with Suction Sheathunder general anesthesia with the patient in the lithotomy position. A 6 Fr ureteral catheter will first be placed into the ureter, followed by retrograde pyelography to assess the upper urinary tract. A guidewire will then be advanced into the renal pelvis. either a 12/14 Fr or 11/13 Fr tip-bendable S-UAS will be inserted. If insertion is not possible due to ureteral narrowing, a smaller 10/12 Fr UAS will be attempted. if failed, a double-J stent will be placed and the procedure terminated, with a second session scheduled 4 weeks later. fURS will be performed using digital flexible ureteroscopes either 8.5 Fr or 7.5 Fr according to UAS size; an 8.5-Fr scope for a 12/14 Fr UAS, and a 7.5-Fr scope for an 11/13-Fr or 10/12-Fr UAS. Stone fragmentation will be performed using a holmium laser (Ho: YAG) with a 272-μm fiber and an energy setting below 30 W. Irrigation will be maintained at 50-100 ml/min and suction pressure at 80-120 mmHg. at the end a 6 Fr JJ will be inserted for 4 weeks. | Procedure or surgery | FURS with Tip-Bendable Suction Sheath |
Primary outcome
stone free rate
Time frame: one month postoperative
The proportion of participants in each treatment arm who are completely free of any stone fragments in the treated kidney, following the initial procedure and without the need for any secondary surgical interventions. Status will be determined by a blinded central radiologist.
2 secondary outcomes
length of hospital stay
Time frame: From date of surgery until date of hospital discharge for 14 days (measured in days).
operative time
Time frame: Measured intraoperatively, from procedure start to end (in minutes).
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 29 Dec 2025.
- Results publication: PubMed 39070176Zhu W, Liu S, Cao J, Wang H, Liang H, Jiang K, Cui Y, Chai CA, Sahinler EB, Aquino A, Mazzon G, Zhong W, Zhao Z, Zhang L, Ding J, Wang Q, Wang Y, Chen KW, Liu Y, Choong S, Sarica K, Zeng G. Tip bendable suction ureteral access sheath versus traditional sheath in retrograde intrarenal stone surgery: an international multicentre, randomized, parallel group, superiority study. EClinicalMedicine. 2024 Jul 5;74:102724. doi: 10.1016/j.eclinm.2024.102724. eCollection 2024 Aug.
- Results publication: PubMed 37483661Tang QL, Liang P, Ding YF, Zhou XZ, Tao RZ. Comparative efficacy between retrograde intrarenal surgery with vacuum-assisted ureteral access sheath and minimally invasive percutaneous nephrolithotomy for 1-2 cm infectious upper ureteral stones: a prospective, randomized controlled study. Front Surg. 2023 Jul 7;10:1200717. doi: 10.3389/fsurg.2023.1200717. eCollection 2023.
- Results publicationSkolarikos A, Jung H, Neisius A, et al. EAU guidelines on urolithiasis. Arnhem, Netherlands: European Association of Urology; 2024.
- Results publication: PubMed 35743499Pauchard F, Ventimiglia E, Corrales M, Traxer O. A Practical Guide for Intra-Renal Temperature and Pressure Management during Rirs: What Is the Evidence Telling Us. J Clin Med. 2022 Jun 15;11(12):3429. doi: 10.3390/jcm11123429.
- Results publication: PubMed 32347334Guven S, Yigit P, Tuncel A, Karabulut I, Sahin S, Kilic O, Balasar M, Seckiner I, Canda E, Sonmez MG, Tefik T, Boz MY, Atis G, Ergin G, Soytas M, Senel C, Kirac M, Kiremit MC, Akand M, Tugcu V, Erkurt B, Muslumanoglu A, Sarica K. Retrograde intrarenal surgery of renal stones: a critical multi-aspect evaluation of the outcomes by the Turkish Academy of Urology Prospective Study Group (ACUP Study). World J Urol. 2021 Feb;39(2):549-554. doi: 10.1007/s00345-020-03210-2. Epub 2020 Apr 28.
- Results publication: PubMed 26077357Geraghty R, Abourmarzouk O, Rai B, Biyani CS, Rukin NJ, Somani BK. Evidence for Ureterorenoscopy and Laser Fragmentation (URSL) for Large Renal Stones in the Modern Era. Curr Urol Rep. 2015 Aug;16(8):54. doi: 10.1007/s11934-015-0529-3.
- Results publication: PubMed 38789313Gauhar V, Traxer O, Castellani D, Sietz C, Chew BH, Fong KY, Hamri SB, Gokce MI, Gadzhiev N, Galosi AB, Yuen SKK, El Hajj A, Ko R, Zawadzki M, Sridharan V, Lakmichi MA, Corrales M, Malkhasyan V, Ragoori D, Soebhali B, Tan K, Chai CA, Tursunkulov AN, Tanidir Y, Persaud S, Elshazly M, Kamal W, Tefik T, Shrestha A, Tiong HC, Somani BK. Could Use of a Flexible and Navigable Suction Ureteral Access Sheath Be a Potential Game-changer in Retrograde Intrarenal Surgery? Outcomes at 30 Days from a Large, Prospective, Multicenter, Real-world Study by the European Association of Urology Urolithiasis Section. Eur Urol Focus. 2024 Dec;10(6):975-982. doi: 10.1016/j.euf.2024.05.010. Epub 2024 May 24.
- Results publication: PubMed 29264133Alenezi H, Denstedt JD. Flexible ureteroscopy: Technological advancements, current indications and outcomes in the treatment of urolithiasis. Asian J Urol. 2015 Jul;2(3):133-141. doi: 10.1016/j.ajur.2015.06.002. Epub 2015 Jun 23.
- 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 Higazy, Lecturer of Urology contact
Ahmed M Tawfeek, assistant proffessor study chair
Ain Shams University, Department Of Urology
Ahmed Higazy, lecturer of urology study director
Ain Shams University, Department Of Urology
Ashraf Satour, lecturer of urology study director
Ain Shams University, Department Of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mini-percutaneous nephrolithotomy and Flexible Uerteroscopy with Tip-Bendable Suction Sheath in people with Stone;Renal and Stone, Urinary, run by Ain Shams 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 2 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: looking for participants now, as of the sponsor's last update on 29 Dec 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?
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 Mohamed M Hasab Allah, resident (+201012663766, Mohamed-Hasaballah@med.asu.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 (time frame: one month postoperative). 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 NCT07306819, which also lists 8 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 29 Dec 2025.