ILY Robotic System vs Manual Flexible Ureteroscopy for Kidney Stone Treatment

Albert El Hajj152 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

152

Conditions

Kidney Stones Urolithiasis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 30 days after the index procedure

Secondary Outcomes

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.

Time frame: Perioperatively and 30 days after the procedure

Ergonomics

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

Time frame: 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.

Time frame: During the procedure

Intraoperative Parameters

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

Time frame: 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.

Time frame: During the procedure

ILY Robotic System vs Manual Flexible Ureteroscopy for Kidney Stone Treatment

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts