An interventional study of Robotic-Assisted Flexible Ureteroscopy and Manual Flexible Ureteroscopy in Kidney Stones and Urolithiasis, sponsored by Albert El Hajj. Recruiting at 1 site in Lebanon. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-30.
Sponsored by Albert El Hajj · Not applicable, Interventional, and Treatment
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.
Participants will:
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's planned enrollment of 152 is above the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →This is the only study on the registry with Albert El Hajj as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants undergo flexible ureteroscopy using the ILY® robotic system.
Procedure: Robotic-Assisted Flexible Ureteroscopy
Participants undergo standard manual flexible ureteroscopy.
Procedure: Manual Flexible Ureteroscopy
Use of the ILY® robotic system to perform flexible ureteroscopy.
Conventional flexible ureteroscopy performed manually by the surgeon.
Efficacy assessed by measuring the stone-free rate (SFR)
A patient is considered stone free if there are no visible residual stone fragments after the treatment.
Time frame: 30 days after the index procedure
Perioperative and 30-day Postoperative Outcomes
This assessment will account for any complications related to the patient's clinical condition from the procedure through a 4-week postoperative period.
Time frame: Perioperatively and 30 days after the procedure
Ergonomics
The NASA Task Load Index will be used to assess for ergonomics.
Time frame: Immediately after the procedure
Surgeon safety in terms of radiation exposure
Surgeon safety from ionizing radiation will be assessed by the surgeon wearing 3 dosimeter badges used to detect and record exposure.
Time frame: During the procedure
Intraoperative Parameters
Operative time, draping time, docking time, lasing time (all measured in minutes)
Time frame: During the procedure
Conversion rate
The proportion of cases where a procedure originally planned using the robotic technique had to be converted to manual fURS due to complications, technical difficulties, or failure of equipment.
Time frame: During the procedure
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Coded participant data, including baseline characteristics, primary and secondary outcome measures, and statistical analysis plans will be made available upon reasonable request from the corresponding author. The study protocol, statistical analysis plan, and informed consent forms will also be accessible upon request. Researchers seeking data must submit a methodologically sound proposal, which will be reviewed by the trial steering committee. Data will be shared in compliance with institutional and ethical regulations.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning six months after publication and ending five years after the publication date
Started May 2025 (actual). Primary completion is estimated for Apr 2027, 23 months after the start.
Of 183 non-industry interventional studies with no phase under Kidney Calculi, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's planned 23 months is below that.
Counting every sponsor, half of 199 studies reached it within 26 months; a quarter within 12 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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