Clinical trial NCT06996587: ILY Robotic System vs Manual Flexible Ureteroscopy for Kidney Stone Treatment
Official title: A Randomized Controlled Trial Comparing Efficacy, Ergonomics, and Safety of ILY Robotic System vs Manual Flexible Ureteroscopy in Patients Undergoing Laser Lithotripsy for Kidney Stones
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Stones
Urolithiasis
Keywords: kidney stones
manual flexible ureteroscopy
fURS
ILY robot
robotic
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the efficacy, ergonomics, and safety of robotic versus manual flexible ureteroscopy (fURS) for kidney stone treatment in adult patients undergoing laser lithotripsy.

* Does robotic-assisted lithotripsy using the ILY® robot have the same efficacy as the manual fURS in treating kidney stones?
* Is robotic flexible ureteroscopy associated with similar or improved safety outcomes, including perioperative and 30-day postoperative complication rates?
* Does the robotic system offer improved ergonomics, lower surgeon radiation exposure, and favorable intraoperative metrics compared to manual flexible ureteroscopy? Researchers will compare the ILY robotic system with manual fURS to see if robotic intervention can match or improve clinical and ergonomic outcomes.

Participants will:

* Be randomly assigned to undergo laser lithotripsy with either the ILY robot or manual flexible ureteroscopy
* Complete standard pre- and postoperative assessments
* Undergo evaluation for stone-free status using a non-contrast CT scan at 30 days postoperatively
* Undergo evaluation for postoperative complications


Eligibility criteria: Inclusion Criteria:

* Males or females ≥ 18 years old
* Patients with a normal pelvicalyceal anatomy
* Patients with renal stone diagnosis confirmed by noncontrast computed tomography regardless of stone size, location, and multiplicity
* ASA score I-III
* Intact mental and cognitive ability to provide informed consent and willingness to participate in the study with 30-day follow-up

Exclusion Criteria:

* Children \< 18 and pregnant women
* Patients with anatomically anomalous kidneys, known case of stricture or stenosis, or recent 3-month history of ureteroscopy (DJ stent placement only will be accepted) or known history of complicated ureteroscopy
* Patients in whom stone measurement was not feasible on NCCT or those with concomitant ureteric stones.
* ASA score IV
* Mentally incapacitated patients unable to provide informed consent

Primary outcomes:
measure: Efficacy assessed by measuring the stone-free rate (SFR)
timeFrame: 30 days after the index procedure
Secondary outcomes:
measure: Perioperative and 30-day Postoperative Outcomes
timeFrame: Perioperatively and 30 days after the procedure
measure: Ergonomics
timeFrame: Immediately after the procedure
measure: Surgeon safety in terms of radiation exposure
timeFrame: During the procedure
measure: Intraoperative Parameters
timeFrame: During the procedure
measure: Conversion rate
timeFrame: During the procedure
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
References: