Renal CalculiCLEAR-URSNCT07463157
FANS vs Standard Ureteral Access Sheath in fURS
A study testing Standard ureteral access sheath and Flexible and Navigable Suction (FANS) Ureteral Access Sheath in people with Renal Calculi, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
This is a prospective, interventional single blinded, randomized, single-center study designed to compare the efficacy of a ureteral access sheath with integrated suction (FANS) versus a standard ureteral access sheath (UAS) in patients undergoing ureterorenoscopy and laser lithotripsy for renal stones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Calculi
- What is being tested?
- Standard ureteral access sheath and Flexible and Navigable Suction (FANS) Ureteral Access Sheath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2026to Jan 2029
- 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
- Participant is willing and able to provide written informed consent before any study-specific procedures are performed.
- Male or female, aged 18 years or older.
- Diagnosed with renal calculi ≥5 mm in diameter, confirmed by imaging, and eligible for fURS with laser lithotripsy according to European Association of Urology (EAU) guidelines.
- In stable general health and fit for elective endoscopic surgery under general anesthesia.
- Willing and able to comply with all study-related procedures, including follow-up imaging and clinical assessments.
- -
Who cannot join
- Solitary kidney (monorenal patients).
- Untreated positive urine culture or ongoing urinary tract infection not resolved with appropriate antibiotic therapy prior to surgery.
- Known anatomical abnormalities of the urinary tract that may interfere with ureteroscopic access or device placement (e.g., ureteral stricture, congenital malformations).
- Pregnancy or breastfeeding at the time of enrollment or planning pregnancy during the study period. In all female patients, a Gravindex test is performed on the day of admission; contraceptive measures are not required
- Concomitant ureteral stone
- Ureteral stenosis
Show all 9Show fewer
- Known allergy or hypersensitivity to materials used in the investigational or control ureteral access sheath.
- Any severe comorbid condition (e.g., uncontrolled cardiovascular disease, severe coagulopathy, active malignancy) that in the opinion of the investigator would interfere with study participation or increase procedural risk.
- Any psychological, cognitive, or social condition that may limit the ability to provide informed consent or comply with follow-up procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Study on the Efficacy of the Ureteral Access Sheath With Integrated Suction FANS Versus the Standard Sheath in Patients With Renal Calculi Undergoing Ureterorenoscopy and Laser Lithotripsy: a Prospective, Randomized, Interventional, Single-center Study
This is a prospective, interventional single blinded, randomized, single-center study designed to compare the efficacy of a ureteral access sheath with integrated suction (FANS) versus a standard ureteral access sheath (UAS) in patients undergoing ureterorenoscopy and laser lithotripsy for renal stones. The hypothesis is that the use of the FANS device improves stone-free rates and reduces postoperative infectious complications compared to the standard sheath.
Read the detailed description
Single-center, prospective, randomized, interventional, single blinded study. Participants with renal calculi undergoing ureterorenoscopy and laser lithotripsy will be randomized in a 1:1 ratio to receive either a standard ureteral access sheath (UAS) or the FANS (Flexible and Navigable Suction) sheath. Randomization will be stratified by stone characteristics, specifically stone density (≤1000 vs >1000 HU) and stone volume (<500 vs ≥500 mm³), as recorded on preoperative imaging, to reduce potential imbalance between study arms.
- Conditions
- Renal Calculi
- Being tested
- Standard ureteral access sheath, Flexible and Navigable Suction (FANS) Ureteral Access Sheath
- Keywords
- Renal calculi, Kidney stones, Ureterorenoscopy, Laser lithotripsy, Ureteral access sheath, FANS device
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ureteral access sheathDevice
Participants undergo flexible ureterorenoscopy and laser lithotripsy using a standard ureteral access sheath according to institutional practice.
Flexible and Navigable Suction (FANS) Ureteral Access SheathDevice
The Flexible and Navigable Suction (FANS) ureteral access sheath (Elephant-II), which enables active suction during flexible ureterorenoscopy and laser lithotripsy.
| Study group | Role | What they receive |
|---|---|---|
| Standard Ureteral Access Sheath (UAS) | Experimental | Participants receive the standard ureteral access sheath during ureterorenoscopy and laser lithotripsy. Receives: Device: Standard ureteral access sheath |
| FANS Ureteral Access Sheath (Elephant-II) | Experimental | Participants receive the Flexible and Navigable Suction (FANS) ureteral access sheath during ureterorenoscopy and laser lithotripsy. Receives: Device: Flexible and Navigable Suction (FANS) Ureteral Access Sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological stone-free rate (absence of residual fragments >=4 mm) assessed by low-dose non-contrast CT scan
Proportion of participants classified as stone-free based on radiological evaluation using low-dose non-contrast computed tomography. Stone-free status is defined as absence of residual stone fragments >=4 mm.
Measured: Within 3 months (+/- 1 month) post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CalculiStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Villa, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463157
- Sponsor's protocol ID
- CLEAR-URS
- Acronym
- CLEAR-URS
- Status last verified
- Mar 2026
- First submitted
- 17 Feb 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on the Efficacy of the Ureteral Access Sheath With Integrated Suction FANS Versus the Standard Sheath in Patients With Renal Calculi Undergoing Ureterorenoscopy and Laser Lithotripsy: a Prospective, Randomized, Interventional, Single-center Study
- ClinicalTrials.gov ID
- NCT07463157
- Acronym / sponsor ID
- CLEAR-URS / CLEAR-URS
- Conditions
- Renal Calculi
- Keywords
- Renal calculi, Kidney stones, Ureterorenoscopy, Laser lithotripsy, Ureteral access sheath, FANS device
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, interventional single blinded, randomized, single-center study designed to compare the efficacy of a ureteral access sheath with integrated suction (FANS) versus a standard ureteral access sheath (UAS) in patients undergoing ureterorenoscopy and laser lithotripsy for renal stones. The hypothesis is that the use of the FANS device improves stone-free rates and reduces postoperative infectious complications compared to the standard sheath.
Detailed description
Single-center, prospective, randomized, interventional, single blinded study. Participants with renal calculi undergoing ureterorenoscopy and laser lithotripsy will be randomized in a 1:1 ratio to receive either a standard ureteral access sheath (UAS) or the FANS (Flexible and Navigable Suction) sheath. Randomization will be stratified by stone characteristics, specifically stone density (≤1000 vs >1000 HU) and stone volume (<500 vs ≥500 mm³), as recorded on preoperative imaging, to reduce potential imbalance between study arms.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Ureteral Access Sheath (UAS) | Experimental | Device: Standard ureteral access sheathParticipants receive the standard ureteral access sheath during ureterorenoscopy and laser lithotripsy. |
| FANS Ureteral Access Sheath (Elephant-II) | Experimental | Device: Flexible and Navigable Suction (FANS) Ureteral Access SheathParticipants receive the Flexible and Navigable Suction (FANS) ureteral access sheath during ureterorenoscopy and laser lithotripsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant is willing and able to provide written informed consent before any study-specific procedures are performed.
- Male or female, aged 18 years or older.
- Diagnosed with renal calculi ≥5 mm in diameter, confirmed by imaging, and eligible for fURS with laser lithotripsy according to European Association of Urology (EAU) guidelines.
- In stable general health and fit for elective endoscopic surgery under general anesthesia.
- Willing and able to comply with all study-related procedures, including follow-up imaging and clinical assessments.
Key exclusion criteria (9 listed)
- Solitary kidney (monorenal patients).
- Untreated positive urine culture or ongoing urinary tract infection not resolved with appropriate antibiotic therapy prior to surgery.
- Known anatomical abnormalities of the urinary tract that may interfere with ureteroscopic access or device placement (e.g., ureteral stricture, congenital malformations).
- Pregnancy or breastfeeding at the time of enrollment or planning pregnancy during the study period. In all female patients, a Gravindex test is performed on the day of admission; contraceptive measures are not required
- Concomitant ureteral stone
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 |
|---|---|---|
| Standard ureteral access sheathParticipants undergo flexible ureterorenoscopy and laser lithotripsy using a standard ureteral access sheath according to institutional practice. | Device | Standard Ureteral Access Sheath (UAS) |
| Flexible and Navigable Suction (FANS) Ureteral Access SheathThe Flexible and Navigable Suction (FANS) ureteral access sheath (Elephant-II), which enables active suction during flexible ureterorenoscopy and laser lithotripsy. | Device | FANS Ureteral Access Sheath (Elephant-II) |
Primary outcome
Radiological stone-free rate (absence of residual fragments >=4 mm) assessed by low-dose non-contrast CT scan
Time frame: Within 3 months (+/- 1 month) post-procedure
Proportion of participants classified as stone-free based on radiological evaluation using low-dose non-contrast computed tomography. Stone-free status is defined as absence of residual stone fragments >=4 mm.
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 12 Mar 2026.
- 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 Standard ureteral access sheath and Flexible and Navigable Suction (FANS) Ureteral Access Sheath in people with Renal Calculi, run by IRCCS San Raffaele at 1 site in Italy.
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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 12 Mar 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 Italy. 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 Luca LV Villa (0226439742, villa.luca@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological stone-free rate (absence of residual fragments >=4 mm) assessed by low-dose non-contrast CT scan (time frame: Within 3 months (+/- 1 month) post-procedure). 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 12 Mar 2026.