Kidney CalculiNCT07289230
Sheathless, Traditional, and Suction Access Sheath RIRS for Renal Stones ≤2 cm
A study testing Traditional ureteral access sheath retrograde intrarenal surgery, Suction ureteral access sheath retrograde intrarenal surgery and Sheathless retrograde intrarenal surgery in people with Kidney Calculi and Renal Calculi, run by Ain Shams University at 1 site in Egypt.
Trial summary
This completed randomized clinical study was designed to compare three different techniques of retrograde intrarenal surgery (retrograde intrarenal surgery) for the treatment of kidney stones that are 2 centimeters or smaller. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Calculi, Renal Calculi, Urolithiasis
- What is being tested?
- Traditional ureteral access sheath retrograde intrarenal surgery, Suction ureteral access sheath retrograde intrarenal surgery and Sheathless retrograde intrarenal surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2024to 30 Aug 2025
- 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
- Adult patients aged 18 years or older.
- Symptomatic unilateral single renal stone with a maximal diameter from 1 centimeter to 2 centimeters.
- Normal kidney function based on routine laboratory tests.
- Patients willing and able to provide written informed consent to participate in the clinical study.
Who cannot join
- Patients with active urinary tract infection (UTI) until appropriate treatment is completed and infection is cleared.
- Patients with anatomical abnormalities of the urinary tract (for example, congenital or acquired structural abnormalities).
- Pregnant patients.
- Patients who are medically unfit for general anesthesia.
- Patients with multiple renal stones in the same kidney or bilateral renal stones.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ain Shams University Hospitals - Department of Urology
Cairo, Cairo Governorate, 11511
About this study
Official title: A Comparative Study Between Sheathless RIRS, Traditional Access Sheath RIRS, and Suction Access Sheath RIRS in the Management of Renal Stones ≤ 2 cm: A Randomized Controlled Clinical Trial
This completed randomized clinical study was designed to compare three different techniques of retrograde intrarenal surgery (retrograde intrarenal surgery) for the treatment of kidney stones that are 2 centimeters or smaller. Retrograde intrarenal surgery is a minimally invasive procedure in which a flexible scope is passed through the urinary tract to reach the kidney and fragment the stone.
The clinical study included three groups of patients. The first group underwent retrograde intrarenal surgery using a traditional ureteral access sheath, which is a hollow tube placed in the ureter to facilitate the passage of instruments and help control pressure inside the kidney. The second group underwent retrograde intrarenal surgery using a suction ureteral access sheath, which combines the function of a traditional sheath with gentle suction to help remove stone fragments and reduce internal pressure. The third group underwent sheathless retrograde intrarenal surgery, in which the flexible surgical scope is inserted directly without the use of any ureteral access sheath.
The purpose of this clinical study was to determine whether these three approaches differ in terms of stone clearance, operative time, intraoperative complications such as bleeding or fluid leakage, and early postoperative complications such as fever or infection. All participants were adults with a single kidney stone between 1 and 2 centimeters, normal kidney function, and no active infection or anatomical abnormalities. All procedures were performed at Ain Shams University Hospitals using the same surgical equipment and technique to ensure comparability between groups.
- Conditions
- Kidney Calculi, Renal Calculi, Urolithiasis, Nephrolithiasis
- Being tested
- Traditional ureteral access sheath retrograde intrarenal surgery, Suction ureteral access sheath retrograde intrarenal surgery, Sheathless retrograde intrarenal surgery
- Keywords
- Kidney stones, Renal calculi, Urolithiasis, Endoscopic management of kidney stones, Retrograde intrarenal surgery, Flexible ureterorenoscopy, Ureteral access sheath, Suction ureteral access sheath, Sheathless retrograde intrarenal surgery, Minimally invasive urologic surgery
- Medical subject headings
- Kidney Calculi, Urolithiasis, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional ureteral access sheath retrograde intrarenal surgeryProcedure or surgery
This intervention involves performing retrograde intrarenal surgery using a traditional ureteral access sheath to facilitate entry of the flexible ureteroscope and maintain controlled intrarenal pressure. The procedure includes endoscopic fragmentation of renal calculi using a holmium:yttrium-aluminum-garnet laser device and placement of a double-J ureteral stent at the end of surgery.
Suction ureteral access sheath retrograde intrarenal surgeryProcedure or surgery
This intervention uses a suction ureteral access sheath that provides continuous negative pressure during retrograde intrarenal surgery. The system assists in evacuation of stone debris and helps control intrarenal pressure while the flexible ureteroscope and holmium:yttrium-aluminum-garnet laser device are used for stone fragmentation. A double-J ureteral stent is placed after the procedure.
Sheathless retrograde intrarenal surgeryProcedure or surgery
This intervention involves performing retrograde intrarenal surgery without the use of any ureteral access sheath. The flexible ureteroscope is introduced directly over a guidewire to access the renal collecting system for laser fragmentation of the stone using a holmium:yttrium-aluminum-garnet laser device. A double-J ureteral stent is inserted following completion of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Ureteral Access Sheath Retrograde Intrarenal Surgery | Active comparator | Participants in this arm underwent retrograde intrarenal surgery (retrograde intrarenal surgery) using a traditional ureteral access sheath. A flexible ureteroscope was advanced through an 11 French by 13 French ureteral access sheath positioned near the ureteropelvic junction. Irrigation was maintained at 50 to 100 milliliters per minute. Stone fragmentation was performed using a holmium:yttrium-aluminum-garnet laser device. All patients received a six French double-J stent at the end of the procedure. Intraoperative complications were recorded, and postoperative imaging was performed for outcome assessment. Receives: Procedure: Traditional ureteral access sheath retrograde intrarenal surgery |
| Suction Ureteral Access Sheath Retrograde Intrarenal Surgery | Experimental | Participants in this arm underwent retrograde intrarenal surgery (retrograde intrarenal surgery) with the use of a suction ureteral access sheath. An 11 French suction ureteral access sheath was inserted over a guidewire and positioned in the renal pelvis. The suction system was connected to a vacuum device, with negative pressure set between 2 and 7 kilopascals to facilitate evacuation of stone fragments and reduce intrarenal pressure. The same flexible ureteroscope and holmium:yttrium-aluminum-garnet laser lithotripsy technique were used as in the traditional arm. A six French double-J stent was inserted at the end of the operation. All intraoperative and postoperative findings were documented. Receives: Procedure: Suction ureteral access sheath retrograde intrarenal surgery |
| Sheathless Retrograde Intrarenal Surgery | Experimental | Participants in this arm underwent sheathless retrograde intrarenal surgery (retrograde intrarenal surgery), in which the flexible ureteroscope was inserted directly over a guidewire without the placement of any ureteral access sheath. Stone fragmentation was performed using a holmium:yttrium-aluminum-garnet laser device. A six French double-J stent was placed at the end of the procedure. Any intraoperative complications, such as bleeding or extravasation, were documented, and postoperative imaging was conducted to assess stone clearance. Receives: Procedure: Sheathless retrograde intrarenal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-free rate assessed by non-contrast computed tomography of the urinary tract
Stone-free status is evaluated using non-contrast computed tomography of the urinary tract performed after surgery. Residual stone fragments are classified into four grades: Grade A, no stones detected (absolute stone-free); Grade B, residual fragments less than or equal to 2 millimeters (relative stone-free); Grade C, residual fragments 2.1 to 4 millimeters (relative stone-free); and Grade D, residual fragments greater than 4 millimeters (significant residual stones). The primary endpoint is the proportion of patients achieving stone-free status, defined as Grade A (absolute stone-free) and, in a secondary analysis, Grades A to C combined (clinically insignificant residual fragments).
Measured: One month after surgery (non-contrast computed tomography of the urinary tract performed approximately 30 days postoperatively)
Secondary outcomes (1)
Operative time for retrograde intrarenal surgery
Operative time is measured in minutes from the insertion of the endoscopic instruments at the beginning of retrograde intrarenal surgery until completion of the procedure, including placement of the double-J ureteral stent. The metric is the mean operative time and distribution of operative time for each study arm.
Measured: During the surgical procedure on the day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start30 Dec 2024
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Model description
- Participants were randomly assigned in a parallel fashion to one of three study arms: traditional ureteral access sheath retrograde intrarenal surgery (RIRS), suction ureteral access sheath retrograde intrarenal surgery (RIRS), or sheathless retrograde intrarenal surgery (RIRS). Each participant received only one of the three techniques, and the groups were followed and compared concurrently regarding stone clearance, operative time, intraoperative complications, and early postoperative complications.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AbdAlhameed Naser, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289230
- Sponsor's protocol ID
- FMASU_MS400_2025
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results of the completed clinical study will be made available to qualified researchers upon reasonable request. Shared data will include de-identified clinical information related to baseline characteristics, operative details, postoperative outcomes, and imaging-based assessments. No information that could directly identify a participant will be shared. Data will be provided for the purpose of scientific validation, secondary analysis, or meta-analysis.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Sheathless RIRS, Traditional Access Sheath RIRS, and Suction Access Sheath RIRS in the Management of Renal Stones ≤ 2 cm: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07289230
- Acronym / sponsor ID
- FMASU_MS400_2025
- Conditions
- Kidney Calculi, Renal Calculi, Urolithiasis, Nephrolithiasis
- Keywords
- Kidney stones, Renal calculi, Urolithiasis, Endoscopic management of kidney stones, Retrograde intrarenal surgery, Flexible ureterorenoscopy, Ureteral access sheath, Suction ureteral access sheath
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 17 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 completed randomized clinical study was designed to compare three different techniques of retrograde intrarenal surgery (retrograde intrarenal surgery) for the treatment of kidney stones that are 2 centimeters or smaller. Retrograde intrarenal surgery is a minimally invasive procedure in which a flexible scope is passed through the urinary tract to reach the kidney and fragment the stone.
The clinical study included three groups of patients. The first group underwent retrograde intrarenal surgery using a traditional ureteral access sheath, which is a hollow tube placed in the ureter to facilitate the passage of instruments and help control pressure inside the kidney. The second group underwent retrograde intrarenal surgery using a suction ureteral access sheath, which combines the function of a traditional sheath with gentle suction to help remove stone fragments and reduce internal pressure. The third group underwent sheathless retrograde intrarenal surgery, in which the flexible surgical scope is inserted directly without the use of any ureteral access sheath.
The purpose of this clinical study was to determine whether these three approaches differ in terms of stone clearance, operative time, intraoperative complications such as bleeding or fluid leakage, and early postoperative complications such as fever or infection. All participants were adults with a single kidney stone between 1 and 2 centimeters, normal kidney function, and no active infection or anatomical abnormalities. All procedures were performed at Ain Shams University Hospitals using the same surgical equipment and technique to ensure comparability between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were randomly assigned in a parallel fashion to one of three study arms: traditional ureteral access sheath retrograde intrarenal surgery (RIRS), suction ureteral access sheath retrograde intrarenal surgery (RIRS), or sheathless retrograde intrarenal surgery (RIRS). Each participant received only one of the three techniques, and the groups were followed and compared concurrently regarding stone clearance, operative time, intraoperative complications, and early postoperative complications.
| Arm | Type | Receives |
|---|---|---|
| Traditional Ureteral Access Sheath Retrograde Intrarenal Surgery | Active comparator | Procedure: Traditional ureteral access sheath retrograde intrarenal surgeryParticipants in this arm underwent retrograde intrarenal surgery (retrograde intrarenal surgery) using a traditional ureteral access sheath. A flexible ureteroscope was advanced through an 11 French by 13 French ureteral access sheath positioned near the ureteropelvic junction. Irrigation was maintained at 50 to 100 milliliters per minute. Stone fragmentation was performed using a holmium:yttrium-aluminum-garnet laser device. All patients received a six French double-J stent at the end of the procedure. Intraoperative complications were recorded, and postoperative imaging was performed for outcome assessment. |
| Suction Ureteral Access Sheath Retrograde Intrarenal Surgery | Experimental | Procedure: Suction ureteral access sheath retrograde intrarenal surgeryParticipants in this arm underwent retrograde intrarenal surgery (retrograde intrarenal surgery) with the use of a suction ureteral access sheath. An 11 French suction ureteral access sheath was inserted over a guidewire and positioned in the renal pelvis. The suction system was connected to a vacuum device, with negative pressure set between 2 and 7 kilopascals to facilitate evacuation of stone fragments and reduce intrarenal pressure. The same flexible ureteroscope and holmium:yttrium-aluminum-garnet laser lithotripsy technique were used as in the traditional arm. A six French double-J stent was inserted at the end of the operation. All intraoperative and postoperative findings were documented. |
| Sheathless Retrograde Intrarenal Surgery | Experimental | Procedure: Sheathless retrograde intrarenal surgeryParticipants in this arm underwent sheathless retrograde intrarenal surgery (retrograde intrarenal surgery), in which the flexible ureteroscope was inserted directly over a guidewire without the placement of any ureteral access sheath. Stone fragmentation was performed using a holmium:yttrium-aluminum-garnet laser device. A six French double-J stent was placed at the end of the procedure. Any intraoperative complications, such as bleeding or extravasation, were documented, and postoperative imaging was conducted to assess stone clearance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients aged 18 years or older.
- Symptomatic unilateral single renal stone with a maximal diameter from 1 centimeter to 2 centimeters.
- Normal kidney function based on routine laboratory tests.
- Patients willing and able to provide written informed consent to participate in the clinical study.
Key exclusion criteria (5 listed)
- Patients with active urinary tract infection (UTI) until appropriate treatment is completed and infection is cleared.
- Patients with anatomical abnormalities of the urinary tract (for example, congenital or acquired structural abnormalities).
- Pregnant patients.
- Patients who are medically unfit for general anesthesia.
- Patients with multiple renal stones in the same kidney or bilateral renal 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 |
|---|---|---|
| Traditional ureteral access sheath retrograde intrarenal surgeryThis intervention involves performing retrograde intrarenal surgery using a traditional ureteral access sheath to facilitate entry of the flexible ureteroscope and maintain controlled intrarenal pressure. The procedure includes endoscopic fragmentation of renal calculi using a holmium:yttrium-aluminum-garnet laser device and placement of a double-J ureteral stent at the end of surgery. | Procedure or surgery | Traditional Ureteral Access Sheath Retrograde Intrarenal Surgery |
| Suction ureteral access sheath retrograde intrarenal surgeryThis intervention uses a suction ureteral access sheath that provides continuous negative pressure during retrograde intrarenal surgery. The system assists in evacuation of stone debris and helps control intrarenal pressure while the flexible ureteroscope and holmium:yttrium-aluminum-garnet laser device are used for stone fragmentation. A double-J ureteral stent is placed after the procedure. | Procedure or surgery | Suction Ureteral Access Sheath Retrograde Intrarenal Surgery |
| Sheathless retrograde intrarenal surgeryThis intervention involves performing retrograde intrarenal surgery without the use of any ureteral access sheath. The flexible ureteroscope is introduced directly over a guidewire to access the renal collecting system for laser fragmentation of the stone using a holmium:yttrium-aluminum-garnet laser device. A double-J ureteral stent is inserted following completion of the procedure. | Procedure or surgery | Sheathless Retrograde Intrarenal Surgery |
Primary outcome
Stone-free rate assessed by non-contrast computed tomography of the urinary tract
Time frame: One month after surgery (non-contrast computed tomography of the urinary tract performed approximately 30 days postoperatively)
Stone-free status is evaluated using non-contrast computed tomography of the urinary tract performed after surgery. Residual stone fragments are classified into four grades: Grade A, no stones detected (absolute stone-free); Grade B, residual fragments less than or equal to 2 millimeters (relative stone-free); Grade C, residual fragments 2.1 to 4 millimeters (relative stone-free); and Grade D, residual fragments greater than 4 millimeters (significant residual stones). The primary endpoint is the proportion of patients achieving stone-free status, defined as Grade A (absolute stone-free) and, in a secondary analysis, Grades A to C combined (clinically insignificant residual fragments).
1 secondary outcome
Operative time for retrograde intrarenal surgery
Time frame: During the surgical procedure on the day of surgery
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 17 Dec 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results of the completed clinical study will be made available to qualified researchers upon reasonable request. Shared data will include de-identified clinical information related to baseline characteristics, operative details, postoperative outcomes, and imaging-based assessments. No information that could directly identify a participant will be shared. Data will be provided for the purpose of scientific validation, secondary analysis, or meta-analysis.
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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 Traditional ureteral access sheath retrograde intrarenal surgery, Suction ureteral access sheath retrograde intrarenal surgery and Sheathless retrograde intrarenal surgery in people with Kidney Calculi and Renal Calculi, 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 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: finished, as of the sponsor's last update on 17 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?
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 assessed by non-contrast computed tomography of the urinary tract (time frame: One month after surgery (non-contrast computed tomography of the urinary tract performed approximately 30 days 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 17 Dec 2025.