Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06996587

ILY Robotic System vs Manual Flexible Ureteroscopy for Kidney Stone 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.

* 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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Kidney Stones Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American University of Beirut Medical Center

Beirut, 1519, Lebanon

Location status: Recruiting

Location contact

Albert El Hajj, MD

CONTACT

[email protected]

+961-1-350000 ext. 5246, 5800

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robotic-Assisted Flexible Ureteroscopy

Procedure

Use of the ILY® robotic system to perform flexible ureteroscopy.

Manual Flexible Ureteroscopy

Procedure

Conventional flexible ureteroscopy performed manually by the surgeon.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Perioperative and 30-day Postoperative Outcomes

    Time frame: Perioperatively and 30 days after the procedure

    This assessment will account for any complications related to the patient's clinical condition from the procedure through a 4-week postoperative period.

  2. Ergonomics

    Time frame: Immediately after the procedure

    The NASA Task Load Index will be used to assess for ergonomics.

  3. Surgeon safety in terms of radiation exposure

    Time frame: During the procedure

    Surgeon safety from ionizing radiation will be assessed by the surgeon wearing 3 dosimeter badges used to detect and record exposure.

  4. Intraoperative Parameters

    Time frame: During the procedure

    Operative time, draping time, docking time, lasing time (all measured in minutes)

  5. Conversion rate

    Time frame: During the procedure

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Albert El Hajj, MD

CONTACT

[email protected]

+961-1-350000 ext. 5246, 5800

Sponsors and collaborators

Lead sponsor

Albert El Hajj

Other

Registry information

Official study 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

Acronym: iFURS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 30, 2025
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.