ILY Robotic System vs Manual Flexible Ureteroscopy for Kidney Stone Treatment
NCT ID: NCT06996587
Last Updated: 2025-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
152 participants
INTERVENTIONAL
2025-05-01
2027-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Performance of a Robotic Flexible Ureteroscopy (ILY) in Laser Treatment of Nephrolithiasis
NCT03638336
Efficacy of Semi-rigid Ureteroscopic Laser Lithotripsy in the Treatment of Proximal Ureteral Stones: a Randomized Controlled Trial
NCT06489366
Efficacy and Safety of Ureteroscopic Lithotripsy (Including Flexible Ureteroscopy) Without Indwelling Urinary Catheter
NCT06458101
Effectiveness of LASER in Treatment of Ureteric Stones.
NCT06975488
Robotic Flexible Ureteroscopy Versus Standard Flexible Ureteroscopy for Renal Stones
NCT06660914
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Robotic-Assisted fURS Group using the ILY Robot
Participants undergo flexible ureteroscopy using the ILY® robotic system.
Robotic-Assisted Flexible Ureteroscopy
Use of the ILY® robotic system to perform flexible ureteroscopy.
Manual fURS Group
Participants undergo standard manual flexible ureteroscopy.
Manual Flexible Ureteroscopy
Conventional flexible ureteroscopy performed manually by the surgeon.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Robotic-Assisted Flexible Ureteroscopy
Use of the ILY® robotic system to perform flexible ureteroscopy.
Manual Flexible Ureteroscopy
Conventional flexible ureteroscopy performed manually by the surgeon.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Albert El Hajj
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Albert El Hajj
Associate Professor of Urology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
American University of Beirut Medical Center
Beirut, , Lebanon
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BIO-2024-0452
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.