NCT06996587 ILY Robotic System vs Manual Flexible Ureteroscopy for Kidney Stone Treatment
| NCT ID | NCT06996587 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Albert El Hajj |
| Condition | Kidney Stones |
| Study Type | INTERVENTIONAL |
| Enrollment | 152 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 152 participants in total. It began in 2025-05-01 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06996587 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Kidney Stones. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06996587 currently recruiting?
Yes, NCT06996587 is actively recruiting participants. Contact the research team at ae67@aub.edu.lb for enrollment information.
Where is the NCT06996587 trial being conducted?
This trial is being conducted at Beirut, Lebanon.
Who is sponsoring the NCT06996587 clinical trial?
NCT06996587 is sponsored by Albert El Hajj. The trial plans to enroll 152 participants.
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