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ILY Robotic System vs Manual Flexible Ureteroscopy for Kidney Stone Treatment

NCT06996587 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2025-05-30

No results posted yet for this study

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

Conditions

  • Kidney Stones
  • Urolithiasis

Interventions

PROCEDURE

Robotic-Assisted Flexible Ureteroscopy

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

PROCEDURE

Manual Flexible Ureteroscopy

Conventional flexible ureteroscopy performed manually by the surgeon.

Sponsors & Collaborators

  • Albert El Hajj

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2027-04-30
Completion
2027-08-31

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06996587 on ClinicalTrials.gov