Kidney StonesiFURSNCT06996587
ILY Robotic System vs Manual Flexible Ureteroscopy for Kidney Stone Treatment
A study testing Robotic-Assisted Flexible Ureteroscopy and Manual Flexible Ureteroscopy in people with Kidney Stones and Urolithiasis, run by Albert El Hajj at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stones, Urolithiasis
- What is being tested?
- Robotic-Assisted Flexible Ureteroscopy and Manual Flexible Ureteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteLebanon
- Study dates
- 1 May 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lebanon1 site, 1 recruiting
- Recruiting
American University of Beirut Medical Center
Beirut, 1519
Albert El Hajj, MD, +961-1-350000 ext. 5246, 5800, ae67@aub.edu.lb
About this study
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
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.
Read more
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
- Conditions
- Kidney Stones, Urolithiasis
- Being tested
- Robotic-Assisted Flexible Ureteroscopy, Manual Flexible Ureteroscopy
- Keywords
- kidney stones, manual flexible ureteroscopy, fURS, ILY robot, robotic
- Medical subject headings
- Kidney Calculi, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-Assisted Flexible UreteroscopyProcedure or surgery
Use of the ILY® robotic system to perform flexible ureteroscopy.
Manual Flexible UreteroscopyProcedure or surgery
Conventional flexible ureteroscopy performed manually by the surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Robotic-Assisted fURS Group using the ILY Robot | Experimental | Participants undergo flexible ureteroscopy using the ILY® robotic system. Receives: Procedure: Robotic-Assisted Flexible Ureteroscopy |
| Manual fURS Group | Active comparator | Participants undergo standard manual flexible ureteroscopy. Receives: Procedure: Manual Flexible Ureteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after the index procedure
Secondary outcomes (5)
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.
Measured: Perioperatively and 30 days after the procedure
Ergonomics
The NASA Task Load Index will be used to assess for ergonomics.
Measured: 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.
Measured: During the procedure
Intraoperative Parameters
Operative time, draping time, docking time, lasing time (all measured in minutes)
Measured: 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.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start1 May 2025
- Primary completionApr 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albert El Hajj
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Albert El Hajj, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996587
- Sponsor's protocol ID
- BIO-2024-0452
- Acronym
- iFURS
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06996587
- Acronym / sponsor ID
- iFURS / BIO-2024-0452
- Conditions
- Kidney Stones, Urolithiasis
- Keywords
- kidney stones, manual flexible ureteroscopy, fURS, ILY robot, robotic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Albert El HajjUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-Assisted fURS Group using the ILY Robot | Experimental | Procedure: Robotic-Assisted Flexible UreteroscopyParticipants undergo flexible ureteroscopy using the ILY® robotic system. |
| Manual fURS Group | Active comparator | Procedure: Manual Flexible UreteroscopyParticipants undergo standard manual flexible ureteroscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-Assisted Flexible UreteroscopyUse of the ILY® robotic system to perform flexible ureteroscopy. | Procedure or surgery | Robotic-Assisted fURS Group using the ILY Robot |
| Manual Flexible UreteroscopyConventional flexible ureteroscopy performed manually by the surgeon. | Procedure or surgery | Manual fURS Group |
Primary outcome
Efficacy assessed by measuring the stone-free rate (SFR)
Time frame: 30 days after the index procedure
A patient is considered stone free if there are no visible residual stone fragments after the treatment.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-Assisted Flexible Ureteroscopy and Manual Flexible Ureteroscopy in people with Kidney Stones and Urolithiasis, run by Albert El Hajj at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Albert El Hajj, MD (+961-1-350000 ext. 5246, 5800, ae67@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy assessed by measuring the stone-free rate (SFR) (time frame: 30 days after the index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025; AzTrials last refreshed its copy on 26 Oct 2026.