UrolithiasisNCT07286071
Safety and Efficacy of Traditional Versus Flexible and Navigable Suction Sheath in Retrograde Intra-Renal Stone Surgery
A study testing Retrograde intrarenal surgery using a ureteral access sheath with suction and Retrograde intrarenal surgery using a traditional ureteral access sheath in people with Urolithiasis and Kidney Calculi, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study compares two techniques used during RIRS for the treatment of kidney stones measuring up to 20 mm. During RIRS, surgeons often use a device called a UAS to help pass instruments into the urinary system and to assist with the removal of stone fragments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis, Kidney Calculi, Nephrolithiasis
- What is being tested?
- Retrograde intrarenal surgery using a ureteral access sheath with suction and Retrograde intrarenal surgery using a traditional ureteral access sheath
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 1 Dec 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
- Adults aged eighteen years or older
- Male or female participants
- Presence of a single kidney stone measuring up to twenty millimeters
- Candidate for retrograde intrarenal surgery according to clinical evaluation
- Able and willing to provide informed consent
Who cannot join
- Active or untreated urinary infection
- History of open kidney surgery or kidney trauma
- Contraindications to anesthesia, including uncontrolled diabetes, severe cardiac disease, or significant coagulation disorders
- Presence of ureteral narrowing or obstruction at the junction between the ureter and the kidney
- Positive urine culture that does not resolve after appropriate treatment
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: Safety and Efficacy of Using Traditional Ureteral Access Sheath Versus Flexible and Navigable Suction Sheath in Retrograde Intra-Renal Stone Surgery for Renal Stones ≤ 20 mm: A Randomized Controlled Study
This study compares two techniques used during RIRS for the treatment of kidney stones measuring up to 20 mm. During RIRS, surgeons often use a device called a UAS to help pass instruments into the urinary system and to assist with the removal of stone fragments. A traditional UAS allows irrigation fluid and small fragments to flow out passively. A newer type, known as a suction UAS, applies controlled negative pressure to help clear stone fragments more effectively and may reduce pressure inside the kidney during the procedure.
The purpose of this study is to determine whether the suction UAS offers better clinical outcomes than the traditional UAS. The main outcomes assessed include the SFR, the duration of surgery, and complications after the procedure such as fever, sepsis, urinary infection, calyceal injury, or ureteral injury.
In this randomized study, adult patients undergoing RIRS for a single renal stone were assigned to either the suction UAS or the traditional UAS. All patients were followed after surgery to assess stone clearance and any complications. The results of this study aim to provide evidence on whether suction UAS improves safety or effectiveness in RIRS compared with the traditional approach.
- Conditions
- Urolithiasis, Kidney Calculi, Nephrolithiasis
- Being tested
- Retrograde intrarenal surgery using a ureteral access sheath with suction, Retrograde intrarenal surgery using a traditional ureteral access sheath
- Keywords
- Urolithiasis, Kidney Calculi, RIRS, UAS, Suction UAS, Endourology, Laser Lithotripsy, Stone-Free Rate
- Medical subject headings
- Urolithiasis, Kidney Calculi, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde intrarenal surgery using a ureteral access sheath with suctionProcedure or surgery
This intervention involves performing retrograde intrarenal surgery using a ureteral access sheath equipped with a suction mechanism that applies controlled negative pressure to help remove stone fragments and manage pressure inside the kidney during the procedure.
Retrograde intrarenal surgery using a traditional ureteral access sheathProcedure or surgery
This intervention involves performing retrograde intrarenal surgery using a conventional ureteral access sheath without suction, relying on irrigation flow and basket retrieval for stone fragment removal.
| Study group | Role | What they receive |
|---|---|---|
| Suction Ureteral Access Sheath Group | Experimental | Participants in this group underwent retrograde intrarenal surgery using a ureteral access sheath equipped with a suction mechanism. After anesthesia, a guide wire was placed and the ureter was evaluated. The suction ureteral access sheath was inserted over the guide wire and positioned inside the kidney near the stone. Controlled negative pressure was applied to improve removal of stone fragments and to maintain lower pressure inside the kidney during the procedure. Laser lithotripsy was performed, and stone fragments were aspirated through the suction system. A double-J ureteral stent was placed at the end of the procedure. Receives: Procedure: Retrograde intrarenal surgery using a ureteral access sheath with suction |
| Traditional Ureteral Access Sheath Group | Active comparator | Participants in this group underwent retrograde intrarenal surgery using a traditional ureteral access sheath without suction. After anesthesia and guide wire placement, the traditional ureteral access sheath was inserted and positioned below the junction between the ureter and the kidney. Laser lithotripsy was performed in the standard manner. Stone fragments were removed passively using irrigation and by repeatedly retrieving fragments with a basket. A double-J ureteral stent was placed at the end of the procedure. Receives: Procedure: Retrograde intrarenal surgery using a traditional ureteral access sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-free rate
The stone-free rate represents the proportion of participants who show no residual stone fragments or only clinically insignificant small fragments on postoperative imaging. Imaging is performed using non-contrast computed tomography. Findings are classified into four categories based on fragment size: complete clearance, fragments up to two millimeters, fragments between two point one and four millimeters, and fragments larger than four millimeters. The outcome is expressed as the percentage of participants achieving complete clearance or clinically insignificant fragments.
Measured: One month after surgery
Secondary outcomes (5)
Duration of surgery
Total time required to complete the surgical procedure, measured from the insertion of the ureteroscope until placement of the ureteral stent.
Measured: During surgery
Readmission after surgery
Number of participants requiring hospital readmission for pain, infection, or any complication related to the surgery.
Measured: Within one month after surgery
Need for an additional procedure
Proportion of participants requiring a second surgical intervention to remove remaining stone material.
Measured: Within three months after surgery
Urinary infection after surgery
Occurrence of laboratory-confirmed urinary infection requiring medical treatment, classified using the Clavien-Dindo system.
Measured: Within one month after surgery
Systemic infection after surgery
Occurrence of systemic infection requiring medical intervention, including antibiotic therapy or hospitalization, assessed using the Clavien-Dindo classification.
Measured: Within 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 posted16 Dec 2025
- Study start1 Jun 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies 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
- Two groups of participants were assigned in parallel. One group underwent retrograde intrarenal surgery using a ureteral access sheath with suction. The other group underwent retrograde intrarenal surgery using a traditional ureteral access sheath without suction. Both groups were followed to compare safety and effectiveness outcomes.
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan mahmoud hassan, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286071
- Sponsor's protocol ID
- FMASU_MS401_2025
- Status last verified
- Feb 2026
- First submitted
- 3 Dec 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data collected during the study will be made available after removal of all direct identifiers. The shared data will include demographic information, clinical characteristics, surgical details, and outcome measurements related to stone clearance and postoperative events. Data will be provided only for the purpose of scientific research and verification of study findings.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Using Traditional Ureteral Access Sheath Versus Flexible and Navigable Suction Sheath in Retrograde Intra-Renal Stone Surgery for Renal Stones ≤ 20 mm: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07286071
- Acronym / sponsor ID
- FMASU_MS401_2025
- Conditions
- Urolithiasis, Kidney Calculi, Nephrolithiasis
- Keywords
- Urolithiasis, Kidney Calculi, RIRS, UAS, Suction UAS, Endourology, Laser Lithotripsy, Stone-Free Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 16 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 compares two techniques used during RIRS for the treatment of kidney stones measuring up to 20 mm. During RIRS, surgeons often use a device called a UAS to help pass instruments into the urinary system and to assist with the removal of stone fragments. A traditional UAS allows irrigation fluid and small fragments to flow out passively. A newer type, known as a suction UAS, applies controlled negative pressure to help clear stone fragments more effectively and may reduce pressure inside the kidney during the procedure.
The purpose of this study is to determine whether the suction UAS offers better clinical outcomes than the traditional UAS. The main outcomes assessed include the SFR, the duration of surgery, and complications after the procedure such as fever, sepsis, urinary infection, calyceal injury, or ureteral injury.
In this randomized study, adult patients undergoing RIRS for a single renal stone were assigned to either the suction UAS or the traditional UAS. All patients were followed after surgery to assess stone clearance and any complications. The results of this study aim to provide evidence on whether suction UAS improves safety or effectiveness in RIRS compared with the traditional approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups of participants were assigned in parallel. One group underwent retrograde intrarenal surgery using a ureteral access sheath with suction. The other group underwent retrograde intrarenal surgery using a traditional ureteral access sheath without suction. Both groups were followed to compare safety and effectiveness outcomes.
| Arm | Type | Receives |
|---|---|---|
| Suction Ureteral Access Sheath Group | Experimental | Procedure: Retrograde intrarenal surgery using a ureteral access sheath with suctionParticipants in this group underwent retrograde intrarenal surgery using a ureteral access sheath equipped with a suction mechanism. After anesthesia, a guide wire was placed and the ureter was evaluated. The suction ureteral access sheath was inserted over the guide wire and positioned inside the kidney near the stone. Controlled negative pressure was applied to improve removal of stone fragments and to maintain lower pressure inside the kidney during the procedure. Laser lithotripsy was performed, and stone fragments were aspirated through the suction system. A double-J ureteral stent was placed at the end of the procedure. |
| Traditional Ureteral Access Sheath Group | Active comparator | Procedure: Retrograde intrarenal surgery using a traditional ureteral access sheathParticipants in this group underwent retrograde intrarenal surgery using a traditional ureteral access sheath without suction. After anesthesia and guide wire placement, the traditional ureteral access sheath was inserted and positioned below the junction between the ureter and the kidney. Laser lithotripsy was performed in the standard manner. Stone fragments were removed passively using irrigation and by repeatedly retrieving fragments with a basket. A double-J ureteral stent was placed at the end of the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged eighteen years or older
- Male or female participants
- Presence of a single kidney stone measuring up to twenty millimeters
- Candidate for retrograde intrarenal surgery according to clinical evaluation
- Able and willing to provide informed consent
Key exclusion criteria (5 listed)
- Active or untreated urinary infection
- History of open kidney surgery or kidney trauma
- Contraindications to anesthesia, including uncontrolled diabetes, severe cardiac disease, or significant coagulation disorders
- Presence of ureteral narrowing or obstruction at the junction between the ureter and the kidney
- Positive urine culture that does not resolve after appropriate treatment
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 surgery using a ureteral access sheath with suctionThis intervention involves performing retrograde intrarenal surgery using a ureteral access sheath equipped with a suction mechanism that applies controlled negative pressure to help remove stone fragments and manage pressure inside the kidney during the procedure. | Procedure or surgery | Suction Ureteral Access Sheath Group |
| Retrograde intrarenal surgery using a traditional ureteral access sheathThis intervention involves performing retrograde intrarenal surgery using a conventional ureteral access sheath without suction, relying on irrigation flow and basket retrieval for stone fragment removal. | Procedure or surgery | Traditional Ureteral Access Sheath Group |
Primary outcome
Stone-free rate
Time frame: One month after surgery
The stone-free rate represents the proportion of participants who show no residual stone fragments or only clinically insignificant small fragments on postoperative imaging. Imaging is performed using non-contrast computed tomography. Findings are classified into four categories based on fragment size: complete clearance, fragments up to two millimeters, fragments between two point one and four millimeters, and fragments larger than four millimeters. The outcome is expressed as the percentage of participants achieving complete clearance or clinically insignificant fragments.
5 secondary outcomes
Duration of surgery
Time frame: During surgery
Readmission after surgery
Time frame: Within one month after surgery
Need for an additional procedure
Time frame: Within three months after surgery
Urinary infection after surgery
Time frame: Within one month after surgery
Systemic infection after surgery
Time frame: Within one month after 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 11 Feb 2026.
- Individual participant dataSharing planned: Yes. Individual participant data collected during the study will be made available after removal of all direct identifiers. The shared data will include demographic information, clinical characteristics, surgical details, and outcome measurements related to stone clearance and postoperative events. Data will be provided only for the purpose of scientific research and verification of study findings.
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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 Retrograde intrarenal surgery using a ureteral access sheath with suction and Retrograde intrarenal surgery using a traditional ureteral access sheath in people with Urolithiasis and Kidney 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 5 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 11 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. 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 (time frame: One month after surgery). 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 11 Feb 2026.