Actively Recruiting
A Randomized Controlled Trial Comparing Efficacy, Ergonomics, and Safety of ILY Robotic System vs Manual Flexible Ureteroscopy for Laser Lithotripsy in Kidney Stone Patients
Led by Albert El Hajj · Updated on 2025-05-30
152
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing robotic-assisted flexible ureteroscopy using the ILY4 robotic system with manual flexible ureteroscopy for treating kidney stones in adults. The study aims to evaluate whether the robotic system matches or improves efficacy, ergonomics, and safety outcomes, including complication rates and surgeon radiation exposure. The research is designed as a randomized controlled trial to assess these clinical questions in patients undergoing laser lithotripsy for kidney stones. Participants will be randomly assigned to one of two groups: one receiving flexible ureteroscopy performed with the ILY robotic system, and the other receiving standard manual flexible ureteroscopy. Both groups will undergo laser lithotripsy as part of their treatment. The study compares intraoperative parameters, ergonomics, radiation exposure to the surgeon, and conversion rates between the two approaches. During the study, participants will complete standard pre- and postoperative assessments and will be evaluated for stone-free status using a non-contrast CT scan 30 days after the procedure. Researchers will also monitor perioperative and 30-day postoperative complications. The primary outcome is the stone-free rate at 30 days. The study includes safety monitoring and ergonomic assessments immediately and during the procedure. Total participation includes follow-up at 30 days post-procedure.
CONDITIONS
Brief Title
ILY Robotic System vs Manual Flexible Ureteroscopy for Kidney Stone Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Normal pelvicalyceal anatomy
- Confirmed renal stone diagnosis by noncontrast computed tomography, regardless of stone size, location, or multiplicity
- ASA score between I and III
- Mental and cognitive ability to provide informed consent and willingness to participate with 30-day follow-up
You will not qualify if you...
- Children under 18 years and pregnant women
- Anatomically anomalous kidneys or known strictures or stenosis
- History of ureteroscopy within 3 months (except DJ stent placement)
- Known history of complicated ureteroscopy
- Patients where stone measurement was not feasible on NCCT or with concomitant ureteric stones
- ASA score IV
- Mentally incapacitated patients unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of the procedure
Participants undergo flexible ureteroscopy either using the ILY® robotic system or standard manual technique to treat kidney stones.
1 procedure visit (in-person)
Duration - 30 days after the procedure
Participants are monitored for efficacy and safety outcomes, including stone-free status and post-operative recovery.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
American University of Beirut Medical Center
Beirut, Lebanon, 1519
Actively Recruiting
Research Team
A
Albert El Hajj, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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