ILY Robotic System vs Manual Flexible Ureteroscopy for Kidney Stone Treatment
iFURS
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
1 other identifier
interventional
152
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2025
CompletedFirst Submitted
Initial submission to the registry
May 13, 2025
CompletedFirst Posted
Study publicly available on registry
May 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
May 30, 2025
May 1, 2025
1.9 years
May 13, 2025
May 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
30 days after the index procedure
Secondary Outcomes (5)
Perioperative and 30-day Postoperative Outcomes
Perioperatively and 30 days after the procedure
Ergonomics
Immediately after the procedure
Surgeon safety in terms of radiation exposure
During the procedure
Intraoperative Parameters
During the procedure
Conversion rate
During the procedure
Study Arms (2)
Robotic-Assisted fURS Group using the ILY Robot
EXPERIMENTALParticipants undergo flexible ureteroscopy using the ILY® robotic system.
Manual fURS Group
ACTIVE COMPARATORParticipants undergo standard manual flexible ureteroscopy.
Interventions
Use of the ILY® robotic system to perform flexible ureteroscopy.
Conventional flexible ureteroscopy performed manually by the surgeon.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- Albert El Hajjlead
Study Sites (1)
American University of Beirut Medical Center
Beirut, 1519, Lebanon
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Urology
Study Record Dates
First Submitted
May 13, 2025
First Posted
May 30, 2025
Study Start
May 1, 2025
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
May 30, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning six months after publication and ending five years after the publication date
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.