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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Robotic-Assisted Flexible Ureteroscopy
Procedure/SurgeryUse of the ILY® robotic system to perform flexible ureteroscopy.
Manual Flexible Ureteroscopy
Procedure/SurgeryConventional flexible ureteroscopy performed manually by the surgeon.
Treatment groups
152 Participants
are divided into 2 treatment groupsGroup A: Robotic-Assisted fURS Group using the ILY RobotExperimental treatment 1 intervention
Group B: Manual fURS GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy assessed by measuring the stone-free rate (SFR)
A patient is considered stone free if there are no visible residual stone fragments after the treatment.
Time frame
30 days after the index procedureSecondary outcomes
1
Perioperative and 30-day Postoperative Outcomes
This assessment will account for any complications related to the patient's clinical condition from the procedure through a 4-week postoperative period.
Time frame
Perioperatively and 30 days after the procedure2
Ergonomics
The NASA Task Load Index will be used to assess for ergonomics.
Time frame
Immediately after the procedure3
Surgeon safety in terms of radiation exposure
Surgeon safety from ionizing radiation will be assessed by the surgeon wearing 3 dosimeter badges used to detect and record exposure.
Time frame
During the procedure4
Intraoperative Parameters
Operative time, draping time, docking time, lasing time (all measured in minutes)
Time frame
During the procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Albert El Hajj
Lead sponsor
American University of Beirut Medical Center
Sponsor institution
Source ClinicalTrials.gov