ILY Robotic System vs Manual Flexible Ureteroscopy for Kidney Stone Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlbert El Hajj
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Robotic-Assisted Flexible Ureteroscopy
- Manual Flexible Ureteroscopy
Treatment groups
152 Participants
are divided into 2 treatment groupsSponsors and collaborators
Albert El Hajj
Lead sponsor
American University of Beirut Medical Center
Sponsor institution
Source ClinicalTrials.gov