Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06996587

ILY Robotic System vs Manual Flexible Ureteroscopy for Kidney Stone Treatment

Led by Albert El Hajj · Updated on 2025-05-30

152

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

ILY Robotic System vs Manual Flexible Ureteroscopy for Kidney Stone Treatment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males or females 18 years old or older
  • Normal pelvicalyceal anatomy
  • Diagnosis of kidney stones confirmed by noncontrast CT regardless of size, location, or number
  • ASA physical status score I to III
  • Ability to provide informed consent and willingness to complete 30-day follow-up
Not Eligible

You will not qualify if you...

  • Children under 18 years and pregnant women
  • Anatomically abnormal kidneys, known strictures or stenosis, recent ureteroscopy within 3 months (except DJ stent placement), or complicated ureteroscopy history
  • Stones not measurable by CT or presence of ureteric stones
  • ASA physical status score IV
  • Unable to provide informed consent due to mental incapacity

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

American University of Beirut Medical Center

Beirut, Lebanon, 1519

Actively Recruiting

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Research Team

A

Albert El Hajj, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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