NephrolithiasisNCT07058402
RIRS With Flex Suction Sheath vs. PCNL for 2-3 cm Renal Stones
A study testing Retrograde Intrarenal Surgery (RIRS) with Tip-Flexible Suction Access Sheath and Standard Percutaneous Nephrolithotomy (PCNL) in people with Nephrolithiasis, run by Changhai Hospital at 1 site in China.
Trial summary
This is a multicenter, randomized controlled trial comparing retrograde intrarenal surgery (RIRS) using a tip-flexible suction access sheath with standard percutaneous nephrolithotomy (PCNL) for the treatment of 2-3 cm unilateral renal stones. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nephrolithiasis
- What is being tested?
- Retrograde Intrarenal Surgery (RIRS) with Tip-Flexible Suction Access Sheath and Standard Percutaneous Nephrolithotomy (PCNL)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 30 Jun 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years
- American Society of Anesthesiologists (ASA) physical status classification of I-III
- Single renal stone with a diameter between 2-3 cm confirmed by non-contrast CT scan
- Signed written informed consent and willingness to comply with study procedures
Who cannot join
- Anatomical abnormalities of the urinary tract (e.g., horseshoe kidney, ileal conduit)
- Uncontrolled urinary tract infection
- Absolute contraindications for RIRS or PCNL
- Inability to understand or complete study documentation
- Failure to follow study protocol or attend follow-up
- Patients requiring urgent rescue or at high risk for irreversible harm during surgery
- Patients who voluntarily withdraw from the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital, Naval Medical University
Shanghai, Shanghai Municipality, 200433
Xiaofeng Gao, +86-21-13601600968, gxfdoc@sina.com
About this study
Official title: A Multicenter, Randomized Controlled Trial Comparing the Retrograde Intrarenal Surgery With a Tip-Flexible Suction Access Sheath to the Standard Percutaneous Nephrolithotomy for the Treatment of 2-3 cm Unilateral Renal Stones
This is a multicenter, randomized controlled trial comparing retrograde intrarenal surgery (RIRS) using a tip-flexible suction access sheath with standard percutaneous nephrolithotomy (PCNL) for the treatment of 2-3 cm unilateral renal stones. The aim is to evaluate the clinical efficacy and safety of the novel suction sheath-assisted RIRS compared to standard PCNL in terms of stone-free rate and postoperative complications. A total of 308 patients will be enrolled across four centers in China.
Read the detailed description
Kidney stones (renal calculi) are a common urological condition that can lead to pain, infection, and renal dysfunction. For renal stones measuring 2-3 cm, both retrograde intrarenal surgery (RIRS) and percutaneous nephrolithotomy (PCNL) are recognized treatment options. Traditional RIRS is less invasive but may be associated with lower stone-free rates for larger stones. A newly developed tip-flexible suction access sheath (TFS-UAS) allows improved access to renal calyces, reduces intrarenal pressure, and enables efficient stone fragment evacuation through continuous suction.
This study is a prospective, multicenter, randomized controlled trial designed to compare the effectiveness and safety of RIRS using the TFS-UAS versus standard PCNL in patients with unilateral renal stones measuring 2-3 cm. A total of 308 patients aged 18-80 years will be enrolled from four tertiary hospitals in China. Eligible participants will be randomized into two groups to receive either TFS-UAS-assisted RIRS or standard PCNL. The primary endpoint is the stone-free rate (SFR) at 3 months, assessed by CT scan. Secondary outcomes include postoperative infection rates, changes in hemoglobin and procalcitonin levels, hospital stay duration, and pain scores.
This study aims to provide high-quality evidence to guide surgical decision-making in the management of medium-sized kidney stones and to evaluate the potential advantages of the new suction-assisted sheath in minimally invasive endourology.
- Conditions
- Nephrolithiasis
- Being tested
- Retrograde Intrarenal Surgery (RIRS) with Tip-Flexible Suction Access Sheath, Standard Percutaneous Nephrolithotomy (PCNL)
- Keywords
- Renal Calculi, Percutaneous Nephrolithotomy, PCNL, Retrograde Intrarenal Surgery, RIRS, Flexible Suction Access Sheath
- Medical subject headings
- Nephrolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde Intrarenal Surgery (RIRS) with Tip-Flexible Suction Access SheathProcedure or surgery
Participants undergo retrograde intrarenal surgery (RIRS) using a tip-flexible suction access sheath. The procedure involves the insertion of a flexible ureteroscope through the urethra and ureter into the kidney. A novel access sheath with tip-flexible and suction capabilities is used to facilitate stone fragmentation and removal. The goal is to improve stone clearance and reduce intrarenal pressure during the procedure.
Standard Percutaneous Nephrolithotomy (PCNL)Procedure or surgery
Also called RIRS with Tip-Flexible Suction Access Sheath
Participants undergo standard percutaneous nephrolithotomy (PCNL). The procedure involves creating a percutaneous tract into the renal collecting system under imaging guidance, followed by nephroscope insertion to fragment and extract 2-3 cm renal stones. This represents the current standard of care for large renal calculi.
| Study group | Role | What they receive |
|---|---|---|
| Retrograde Intrarenal Surgery (RIRS) with Tip-Flexible Suction Access Sheath | Experimental | Participants in this group will undergo retrograde intrarenal surgery (RIRS) using a tip-flexible suction access sheath for the treatment of 2-3 cm unilateral renal stones. Receives: Procedure: Retrograde Intrarenal Surgery (RIRS) with Tip-Flexible Suction Access Sheath |
| Standard Percutaneous Nephrolithotomy (PCNL) | Experimental | Participants in this group will undergo standard percutaneous nephrolithotomy (PCNL) for the treatment of 2-3 cm unilateral renal stones. Receives: Procedure: Standard Percutaneous Nephrolithotomy (PCNL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-Free Rate (SFR)
The proportion of participants who are stone-free after the procedure, defined as no residual stones or residual fragments <2 mm based on postoperative plain abdominal X-ray or non-contrast CT scan.
Measured: 3 months postoperatively
Secondary outcomes (1)
Incidence of Postoperative Infection (SIRS Criteria)
Number and proportion of participants who develop postoperative systemic inflammatory response syndrome (SIRS), defined as meeting at least 2 of the following:
Temperature >38°C or <36°C
Heart rate >90 bpm
Respiratory rate >20/min or PaCO2 <32 mmHg
WBC count >12×10⁹/L or <4×10⁹/L
Measured: Within 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Apr 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NephrolithiasisStudies 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
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Zhejiang Provincial People's Hospital, Affiliated Hospital of Jiaxing University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058402
- Sponsor's protocol ID
- 20250408
- Status last verified
- Apr 2025
- First submitted
- 28 May 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Skolarikos A, Jung H, Neisius A, et al. EAU Guidelines on Urolithiasis 2024. European Association of Urology. https://uroweb.org/guidelines/urolithiasis
Zeng G, Traxer O, Zhong W, Osther P, Pearle MS, Preminger GM, Mazzon G, Seitz C, Geavlete P, Fiori C, Ghani KR, Chew BH, Git KA, Vicentini FC, Papatsoris A, Brehmer M, Martinez JL, Cheng J, Cheng F, Gao X, Gadzhiev N, Pietropaolo A, Proietti S, Ye Z, Sarica K. International Alliance of Urolithiasis guideline on retrograde intrarenal surgery. BJU Int. 2023 Feb;131(2):153-164. doi: 10.1111/bju.15836. Epub 2022 Jul 12.
PubMed 35733358
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled Trial Comparing the Retrograde Intrarenal Surgery With a Tip-Flexible Suction Access Sheath to the Standard Percutaneous Nephrolithotomy for the Treatment of 2-3 cm Unilateral Renal Stones
- ClinicalTrials.gov ID
- NCT07058402
- Acronym / sponsor ID
- 20250408
- Conditions
- Nephrolithiasis
- Keywords
- Renal Calculi, Percutaneous Nephrolithotomy, PCNL, Retrograde Intrarenal Surgery, RIRS, Flexible Suction Access Sheath
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Zhejiang Provincial People's Hospital, Affiliated Hospital of Jiaxing University
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 10 Jul 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 is a multicenter, randomized controlled trial comparing retrograde intrarenal surgery (RIRS) using a tip-flexible suction access sheath with standard percutaneous nephrolithotomy (PCNL) for the treatment of 2-3 cm unilateral renal stones. The aim is to evaluate the clinical efficacy and safety of the novel suction sheath-assisted RIRS compared to standard PCNL in terms of stone-free rate and postoperative complications. A total of 308 patients will be enrolled across four centers in China.
Detailed description
Kidney stones (renal calculi) are a common urological condition that can lead to pain, infection, and renal dysfunction. For renal stones measuring 2-3 cm, both retrograde intrarenal surgery (RIRS) and percutaneous nephrolithotomy (PCNL) are recognized treatment options. Traditional RIRS is less invasive but may be associated with lower stone-free rates for larger stones. A newly developed tip-flexible suction access sheath (TFS-UAS) allows improved access to renal calyces, reduces intrarenal pressure, and enables efficient stone fragment evacuation through continuous suction.
This study is a prospective, multicenter, randomized controlled trial designed to compare the effectiveness and safety of RIRS using the TFS-UAS versus standard PCNL in patients with unilateral renal stones measuring 2-3 cm. A total of 308 patients aged 18-80 years will be enrolled from four tertiary hospitals in China. Eligible participants will be randomized into two groups to receive either TFS-UAS-assisted RIRS or standard PCNL. The primary endpoint is the stone-free rate (SFR) at 3 months, assessed by CT scan. Secondary outcomes include postoperative infection rates, changes in hemoglobin and procalcitonin levels, hospital stay duration, and pain scores.
This study aims to provide high-quality evidence to guide surgical decision-making in the management of medium-sized kidney stones and to evaluate the potential advantages of the new suction-assisted sheath in minimally invasive endourology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrograde Intrarenal Surgery (RIRS) with Tip-Flexible Suction Access Sheath | Experimental | Procedure: Retrograde Intrarenal Surgery (RIRS) with Tip-Flexible Suction Access SheathParticipants in this group will undergo retrograde intrarenal surgery (RIRS) using a tip-flexible suction access sheath for the treatment of 2-3 cm unilateral renal stones. |
| Standard Percutaneous Nephrolithotomy (PCNL) | Experimental | Procedure: Standard Percutaneous Nephrolithotomy (PCNL)Participants in this group will undergo standard percutaneous nephrolithotomy (PCNL) for the treatment of 2-3 cm unilateral renal stones. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 80 years
- American Society of Anesthesiologists (ASA) physical status classification of I-III
- Single renal stone with a diameter between 2-3 cm confirmed by non-contrast CT scan
- Signed written informed consent and willingness to comply with study procedures
Key exclusion criteria (7 listed)
- Anatomical abnormalities of the urinary tract (e.g., horseshoe kidney, ileal conduit)
- Uncontrolled urinary tract infection
- Absolute contraindications for RIRS or PCNL
- Inability to understand or complete study documentation
- Failure to follow study protocol or attend follow-up
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 (RIRS) with Tip-Flexible Suction Access SheathParticipants undergo retrograde intrarenal surgery (RIRS) using a tip-flexible suction access sheath. The procedure involves the insertion of a flexible ureteroscope through the urethra and ureter into the kidney. A novel access sheath with tip-flexible and suction capabilities is used to facilitate stone fragmentation and removal. The goal is to improve stone clearance and reduce intrarenal pressure during the procedure. | Procedure or surgery | Retrograde Intrarenal Surgery (RIRS) with Tip-Flexible Suction Access Sheath |
| Standard Percutaneous Nephrolithotomy (PCNL)Also: RIRS with Tip-Flexible Suction Access SheathParticipants undergo standard percutaneous nephrolithotomy (PCNL). The procedure involves creating a percutaneous tract into the renal collecting system under imaging guidance, followed by nephroscope insertion to fragment and extract 2-3 cm renal stones. This represents the current standard of care for large renal calculi. | Procedure or surgery | Standard Percutaneous Nephrolithotomy (PCNL) |
Primary outcome
Stone-Free Rate (SFR)
Time frame: 3 months postoperatively
The proportion of participants who are stone-free after the procedure, defined as no residual stones or residual fragments <2 mm based on postoperative plain abdominal X-ray or non-contrast CT scan.
1 secondary outcome
Incidence of Postoperative Infection (SIRS Criteria)
Time frame: Within 72 hours postoperatively
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 10 Jul 2025.
- BackgroundSkolarikos A, Jung H, Neisius A, et al. EAU Guidelines on Urolithiasis 2024. European Association of Urology. https://uroweb.org/guidelines/urolithiasis
- Background: PubMed 35733358Zeng G, Traxer O, Zhong W, Osther P, Pearle MS, Preminger GM, Mazzon G, Seitz C, Geavlete P, Fiori C, Ghani KR, Chew BH, Git KA, Vicentini FC, Papatsoris A, Brehmer M, Martinez JL, Cheng J, Cheng F, Gao X, Gadzhiev N, Pietropaolo A, Proietti S, Ye Z, Sarica K. International Alliance of Urolithiasis guideline on retrograde intrarenal surgery. BJU Int. 2023 Feb;131(2):153-164. doi: 10.1111/bju.15836. Epub 2022 Jul 12.
- 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.
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 (RIRS) with Tip-Flexible Suction Access Sheath and Standard Percutaneous Nephrolithotomy (PCNL) in people with Nephrolithiasis, run by Changhai Hospital at 1 site in China.
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 7 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 10 Jul 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 China. 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 Xiaofeng Gao (+86-21-13601600968, gxfdoc@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone-Free Rate (SFR) (time frame: 3 months postoperatively). 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 NCT07058402, which also lists 2 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 10 Jul 2025; AzTrials last refreshed its copy on 30 Oct 2026.