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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Lebanon
American University of Beirut Medical Center
RECRUITING
Beirut
Contact Information
Primary
Albert El Hajj, MD
ae67@aub.edu.lb
+961-1-350000
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2027-08
Participants
Target number of participants: 152
Treatments
Experimental: Robotic-Assisted fURS Group using the ILY Robot
Participants undergo flexible ureteroscopy using the ILY® robotic system.
Active_comparator: Manual fURS Group
Participants undergo standard manual flexible ureteroscopy.
Sponsors
Leads: Albert El Hajj

This content was sourced from clinicaltrials.gov

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