ILY Robotic System vs Manual Flexible Ureteroscopy for Kidney Stone Treatment (iFURS)

Albert El Hajj

Status: Enrolling

Conditions: Urolithiasis; Kidney Stones

Treatments: Procedure: Robotic-Assisted Flexible Ureteroscopy; Procedure: Manual Flexible Ureteroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06996587

BIO-2024-0452

Details and patient eligibility

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

Enrollment: 152 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

152 participants in 2 patient groups

Robotic-Assisted fURS Group using the ILY Robot

Experimental group

Description:

Participants undergo flexible ureteroscopy using the ILY® robotic system.

Treatment:

Procedure: Robotic-Assisted Flexible Ureteroscopy

Manual fURS Group

Active Comparator group

Description:

Participants undergo standard manual flexible ureteroscopy.

Treatment:

Procedure: Manual Flexible Ureteroscopy