NCT07463157

Brief 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. The hypothesis is that the use of the FANS device improves stone-free rates and reduces postoperative infectious complications compared to the standard sheath.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
32mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Jan 2029

First Submitted

Initial submission to the registry

February 17, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

February 17, 2026

Last Update Submit

March 10, 2026

Conditions

Renal Calculi

Keywords

Renal calculiKidney stonesUreterorenoscopyLaser lithotripsyUreteral access sheathFANS device

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within 3 months (+/- 1 month) post-procedure

Study Arms (2)

Standard Ureteral Access Sheath (UAS)

EXPERIMENTAL

Participants receive the standard ureteral access sheath during ureterorenoscopy and laser lithotripsy.

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.

Device: Flexible and Navigable Suction (FANS) Ureteral Access Sheath

Interventions

Standard ureteral access sheathDEVICE

Participants undergo flexible ureterorenoscopy and laser lithotripsy using a standard ureteral access sheath according to institutional practice.

Standard Ureteral Access Sheath (UAS)
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.

FANS Ureteral Access Sheath (Elephant-II)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Italy

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Luca LV Villa

CONTACT

0226439742villa.luca@hsr.it

Concetta Cangemi

CONTACT

0226435662cangemi.concetta@hsr.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 17, 2026

First Posted

March 11, 2026

Study Start

March 15, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)