Comparing robotic and manual methods for treating kidney stones
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
NA · American University of Beirut Medical Center · NCT06996587
This study is testing whether a robotic system works better than traditional manual methods for treating kidney stones to see which approach is safer and more effective for adults.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 152 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | American University of Beirut Medical Center (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Beirut) |
| Trial ID | NCT06996587 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness, safety, and ergonomics of the ILY robotic system compared to manual flexible ureteroscopy (fURS) in treating kidney stones through laser lithotripsy. Adult participants will be randomly assigned to receive either robotic-assisted or manual ureteroscopy, with assessments conducted before and after the procedure. The study will focus on comparing clinical outcomes, complication rates, and the ergonomic advantages of using robotic technology in this context.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed kidney stones and normal kidney anatomy.
Not a fit: Patients under 18, pregnant women, or those with anatomical anomalies of the kidneys will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for kidney stones, enhancing patient safety and surgical outcomes.
How similar studies have performed: While robotic-assisted procedures are gaining traction, this specific comparison of robotic versus manual ureteroscopy is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beirut
- American University of Beirut Medical Center — Beirut, Lebanon (RECRUITING)
Study contacts
- Study coordinator: Albert El Hajj, MD
- Email: ae67@aub.edu.lb
- Phone: +961-1-350000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Kidney Stones, Urolithiasis, kidney stones, manual flexible ureteroscopy, fURS, ILY robot, robotic