ILY Robotic System vs Manual Flexible Ureteroscopy for Kidney Stone Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robotic-Assisted Flexible Ureteroscopy, Manual Flexible Ureteroscopy.
- Who it may be relevant to
- Registry conditions: Kidney Stones, Urolithiasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Lebanon
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
Interventions
- Procedure Robotic-Assisted Flexible Ureteroscopy
Use of the ILY® robotic system to perform flexible ureteroscopy. - Procedure Manual Flexible Ureteroscopy
Conventional flexible ureteroscopy performed manually by the surgeon.
Primary outcome measures
- Efficacy assessed by measuring the stone-free rate (SFR) [Time frame: 30 days after the index procedure]
Secondary outcome measures (5)
- Perioperative and 30-day Postoperative Outcomes [Time frame: Perioperatively and 30 days after the procedure]
- Ergonomics [Time frame: Immediately after the procedure]
- Surgeon safety in terms of radiation exposure [Time frame: During the procedure]
- Intraoperative Parameters [Time frame: During the procedure]
- Conversion rate [Time frame: During the procedure]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Lebanon · 1 center
- American University of Beirut Medical Center — Beirut
Identifiers
NCT: NCT06996587 · BIO-2024-0452